U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C17H19FN2O2
Molecular Weight 302.3434
Optical Activity UNSPECIFIED
Defined Stereocenters 1 / 1
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of SAFINAMIDE (R)-ISOMER

SMILES

C[C@@H](NCC1=CC=C(OCC2=CC=CC(F)=C2)C=C1)C(N)=O

InChI

InChIKey=NEMGRZFTLSKBAP-GFCCVEGCSA-N
InChI=1S/C17H19FN2O2/c1-12(17(19)21)20-10-13-5-7-16(8-6-13)22-11-14-3-2-4-15(18)9-14/h2-9,12,20H,10-11H2,1H3,(H2,19,21)/t12-/m1/s1

HIDE SMILES / InChI

Description
Curator's Comment: Description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/27536120 | http://adisinsight.springer.com/drugs/800009612

Safinamide (FCE 26743, NW 1015, PNU 151774, PNU 151774E, trade name Xadago) combines potent, selective, and reversible inhibition of MAO-B with blockade of voltage-dependent Na+ and Ca2+ channels and inhibition of glutamate release. Safinamide is under development with Newron, Zambon and Meiji Seika Pharma for the treatment of Parkinson's disease. Safinamide has been launched in the EU, Iceland and Liechtenstein. Safinamide was well tolerated and safe in the clinical development program that demonstrated the amelioration of motor symptoms and OFF phenomena by safinamide when combined with dopamine agonists or levodopa.

CNS Activity

Originator

Approval Year

2017
422
Targets

Targets

Primary TargetPharmacologyConditionPotency
Inhibitor
8297
 98.0 nM [IC50]
Blocker
537
 8.0 µM [IC50]
Inhibitor
8297
 56.4 µM [IC50]
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Primary
Approved
8429
XADAGO

Approved Use

Xadago (safinamide) is indicated for the treatment of adult patients with idiopathic Parkinson’s disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.

Launch Date

2015
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
650 ng/mL
OTHER GOV
https://www.ema.europa.eu/en/documents/assessment-report/xadago-epar-public-assessment-report_en.pdf
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
SAFINAMIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
19000 ng × h/mL
OTHER GOV
https://www.ema.europa.eu/en/documents/assessment-report/xadago-epar-public-assessment-report_en.pdf
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
SAFINAMIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
26 h
OTHER GOV
https://www.ema.europa.eu/en/documents/assessment-report/xadago-epar-public-assessment-report_en.pdf
single, intravenous
 SAFINAMIDE plasma
Homo sapiens
population: UNKNOWN
age: UNKNOWN
sex: UNKNOWN
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
11.5%
OTHER GOV
https://www.ema.europa.eu/en/documents/assessment-report/xadago-epar-public-assessment-report_en.pdf
100 mg single, oral
dose: 100 mg
route of administration: Oral
experiment type: SINGLE
co-administered:
SAFINAMIDE plasma
Homo sapiens
population: HEALTHY
age: ADULT
sex: UNKNOWN
food status: UNKNOWN
Doses

Doses

DosePopulationAdverse events​
400 mg 1 times / day single, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: single
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/24136086/
healthy, mean age 28.7 years
n = 6
Health Status: healthy
Age Group: mean age 28.7 years
Sex: M
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/24136086/
Other AEs: Headache...
Other AEs:
Headache (grade 1, 16.7%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/24136086/
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Disc. AE: ALT increased...
Other AEs: Palpitations, Nausea...
AEs leading to
discontinuation/dose reduction:
ALT increased (5.5%)
Other AEs:
Palpitations (5.5%)
Nausea (5.5%)
Pharyngitis (5.5%)
Headache (5.5%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Other AEs: Diarrhea, Headache...
Other AEs:
Diarrhea (5.5%)
Headache (5.5%)
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
Other AEs: Headache, Dizziness...
Other AEs:
Headache (11.9%)
Dizziness (5.1%)
Nausea (3.4%)
Nasopharyngitis (1.7%)
Fatigue (3.4%)
Vomiting (1.7%)
Diarrhea (1.7%)
Skin laceration (1.7%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Disc. AE: Angina pectoris, Aortic valve incompetence...
AEs leading to
discontinuation/dose reduction:
Angina pectoris (0.3%)
Aortic valve incompetence (0.3%)
Atrial flutter (0.3%)
Creatine phosphokinase increased (0.3%)
Vertigo (0.3%)
Cataract (0.3%)
Lacrimation increased (0.3%)
Macular oedema (0.3%)
Maculopathy (0.3%)
Ocular vascular disorder (0.3%)
Papilloedema (0.3%)
Paraesthesia (0.3%)
Pain of skin (0.3%)
Rash erythematous (0.3%)
Anaemia iron deficiency (0.3%)
Depressed mood (0.3%)
Bronchospasm (0.3%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Disc. AE: Dyskinesia, Parkinson's disease...
AEs leading to
discontinuation/dose reduction:
Dyskinesia (1.4%)
Parkinson's disease (0.6%)
Dizziness (0.2%)
Paraesthesia (0.2%)
Cognitive disorder (0.2%)
Presyncope (0.2%)
Abdominal pain (0.2%)
Vomiting (0.2%)
Hallucination, visual (0.6%)
Hallucination (0.2%)
Sleep terror (0.2%)
Asthenia (0.2%)
Muscle spasms (0.4%)
Basal cell carcinoma (0.2%)
Breast cancer (0.2%)
Non-Hodgkin's lymphoma (0.2%)
Arrhythmia (0.2%)
Ventricular tachycardia (0.2%)
Cataract subcapsular (0.2%)
Vision blurred (0.2%)
Change in ECG (0.2%)
QT interval prolonged (0.2%)
Blister (0.2%)
Hyperhidrosis (0.2%)
Fall (0.2%)
Subdural haematoma (0.2%)
Cachexia (0.2%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Disc. AE: Swollen tongue, Dyspnea...
AEs leading to
discontinuation/dose reduction:
Swollen tongue
Dyspnea
Redness mouth
Gingival swelling
Rash trunk
Decreased appetite
Increased appetite
Inner restlessness
Redness of face
Pruritus
Hyperhidrosis
Dry mouth
Hoarseness
Malaise
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Disc. AE: Dyskinesia, Dizziness...
AEs leading to
discontinuation/dose reduction:
Dyskinesia (1.3%)
Dizziness (0.4%)
Paraesthesia (0.4%)
Balance disorder (0.4%)
Tremor (0.4%)
Abdominal pain (0.4%)
Vomiting (0.4%)
Aphthous stomatitis (0.4%)
Constipation (0.4%)
Nausea (0.4%)
Asthenia (0.4%)
Chest discomfort (0.4%)
Muscle rigidity (0.4%)
Dyspnoea (0.9%)
Pneumonitis (0.4%)
Palpitations (0.4%)
Urinary tract infection (0.4%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Disc. AE: Myocardial infarction, Palpitations...
AEs leading to
discontinuation/dose reduction:
Myocardial infarction (0.4%)
Palpitations (0.4%)
Ventricular tachycardia (0.4%)
QT interval prolonged (0.9%)
Blood glucose increased (0.4%)
Vertigo (0.4%)
Muscle spasms (0.4%)
Tremor (0.4%)
Nausea (0.4%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Disc. AE: Head titubation, Nausea...
AEs leading to
discontinuation/dose reduction:
Head titubation (1.1%)
Nausea (2.2%)
Diarrhea (1.1%)
GERD (1.1%)
Vomiting (1.1%)
Anxiety (1.1%)
Nightmare (1.1%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
AEs

AEs

AESignificanceDosePopulation
Headache grade 1, 16.7%
400 mg 1 times / day single, oral
Highest studied dose
Dose: 400 mg, 1 times / day
Route: oral
Route: single
Dose: 400 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/24136086/
healthy, mean age 28.7 years
n = 6
Health Status: healthy
Age Group: mean age 28.7 years
Sex: M
Population Size: 6
Sources:
https://pubmed.ncbi.nlm.nih.gov/24136086/
Headache 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Nausea 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Palpitations 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Pharyngitis 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
ALT increased 5.5%
Disc. AE
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Co-administed with::
tyramine(100 to 700 mg; 7 days)
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Diarrhea 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Headache 5.5%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
healthy, mean age 41.2 years
n = 18
Health Status: healthy
Age Group: mean age 41.2 years
Sex: M+F
Population Size: 18
Sources:
https://pubmed.ncbi.nlm.nih.gov/22948897/
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Diarrhea 1.7%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
Nasopharyngitis 1.7%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
Skin laceration 1.7%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
Vomiting 1.7%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
Headache 11.9%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
Fatigue 3.4%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
Nausea 3.4%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
Dizziness 5.1%
350 mg 1 times / day multiple, oral
Higher than recommended
Dose: 350 mg, 1 times / day
Route: oral
Route: multiple
Dose: 350 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
healthy
n = 59
Health Status: healthy
Population Size: 59
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000CrossR.pdf
Page: 207145Orig1s000CrossR.pdf - p.13(14)
Anaemia iron deficiency 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Angina pectoris 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Aortic valve incompetence 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Atrial flutter 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Bronchospasm 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Cataract 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Creatine phosphokinase increased 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Depressed mood 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Lacrimation increased 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Macular oedema 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Maculopathy 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Ocular vascular disorder 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Pain of skin 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Papilloedema 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Paraesthesia 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Rash erythematous 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Vertigo 0.3%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 317
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 317
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Abdominal pain 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Arrhythmia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Asthenia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Basal cell carcinoma 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Blister 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Breast cancer 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Cachexia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Cataract subcapsular 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Change in ECG 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Cognitive disorder 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Dizziness 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Fall 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Hallucination 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Hyperhidrosis 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Non-Hodgkin's lymphoma 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Paraesthesia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Presyncope 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
QT interval prolonged 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Sleep terror 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Subdural haematoma 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Ventricular tachycardia 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Vision blurred 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Vomiting 0.2%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Muscle spasms 0.4%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Hallucination, visual 0.6%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Parkinson's disease 0.6%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Dyskinesia 1.4%
Disc. AE
100 mg 1 times / day multiple, oral
Recommended
Dose: 100 mg, 1 times / day
Route: oral
Route: multiple
Dose: 100 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 498
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 498
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Decreased appetite Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Dry mouth Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Dyspnea Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Gingival swelling Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Hoarseness Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Hyperhidrosis Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Increased appetite Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Inner restlessness Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Malaise Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Pruritus Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Rash trunk Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Redness mouth Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Redness of face Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Swollen tongue Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
unhealthy
n = 1
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 1
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.18(19)
Abdominal pain 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Aphthous stomatitis 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Asthenia 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Balance disorder 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Chest discomfort 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Constipation 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Dizziness 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Muscle rigidity 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Nausea 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Palpitations 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Paraesthesia 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Pneumonitis 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Tremor 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Urinary tract infection 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Vomiting 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Dyspnoea 0.9%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Dyskinesia 1.3%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
unhealthy
n = 223
Health Status: unhealthy
Condition: Late/Advanced Stage Parkinson's disease
Population Size: 223
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.124(156)
Blood glucose increased 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Muscle spasms 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Myocardial infarction 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Nausea 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Palpitations 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Tremor 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Ventricular tachycardia 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Vertigo 0.4%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
QT interval prolonged 0.9%
Disc. AE
50 mg 1 times / day multiple, oral
Recommended
Dose: 50 mg, 1 times / day
Route: oral
Route: multiple
Dose: 50 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 226
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 226
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Anxiety 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Diarrhea 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
GERD 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Head titubation 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Nightmare 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Vomiting 1.1%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Nausea 2.2%
Disc. AE
200 mg 1 times / day multiple, oral
Dose: 200 mg, 1 times / day
Route: oral
Route: multiple
Dose: 200 mg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
unhealthy
n = 89
Health Status: unhealthy
Condition: Parkinson’s disease
Population Size: 89
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207145Orig1s000MedR.pdf
Page: 207145Orig1s000MedR.pdf - p.121(153)
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
substrate
1737

inducer
781
inhibitor
1767

inducer
389
inhibitor
1852
inhibitor
1612

OverviewOther

Other InhibitorOther SubstrateOther Inducer
OCT2
647

OATP1B1
788

OATP1B3
706

BSEP
402

BCRP
699

P-gp
1461

CYP2A6
707

CYP2B6
810

CYP2C8
911

CYP2C19
1478

CYP2E1
882

CYP3A4/5
278

CYP1A1
110

CYP1A2
1524

ALDH1
40
ALDH
6

P-gp
1537

UGT1A
7
CYP1A2
701

CYP2B6
547

UGT1A1
69

SULT2A1
4
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BCRP
773
 no [IC50 43 uM]
BSEP
403
 no
CYP1A2
1692
 no
NW-1153
3
CYP1A2
1692
 no
NW-1689
3
CYP2A6
739
 no
CYP2A6
739
 no
NW-1153
3
CYP2A6
739
 no
NW-1689
3
CYP2B6
1001
 no
CYP2B6
1001
 no
NW-1153
3
CYP2B6
1001
 no
NW-1689
3
CYP2C19
1553
 no
CYP2C19
1553
 no
NW-1153
3
CYP2C19
1553
 no
NW-1689
3
CYP2C8
965
 no
CYP2C8
965
 no
NW-1153
3
CYP2C8
965
 no
NW-1689
3
CYP2C9
1819
 no
CYP2C9
1819
 no
NW-1153
3
CYP2C9
1819
 no
NW-1689
3
CYP2D6
1891
 no
CYP2D6
1891
 no
NW-1153
3
CYP2D6
1891
 no
NW-1689
3
CYP2E1
970
 no
CYP2E1
970
 no
NW-1153
3
CYP2E1
970
 no
NW-1689
3
CYP3A4/5
335
 no
CYP3A4/5
335
 no
NW-1153
3
CYP3A4/5
335
 no
NW-1689
3
OATP1B1
803
 no
OATP1B3
715
 no
OCT2
648
 no
P-gp
1650
 no
P-gp
1650
 no
NW-1153
3
SULT2A1
9
 no
UGT1A1
254
 no
BCRP
773
 yes [IC50 3.7 uM]
NW-1689
3
ALDH1
40
 yes [IC50 35 uM]
NW-1689
3
CYP1A1
218
 yes [IC50 47.7 uM]
CYP1A2
1692
 yes
CYP2B6
1001
 yes
CYP2C9
1819
 yes
CYP3A4
1925
 yes
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
CYP3A4
1737
 minor
P-gp
1537
 no
ALDH
6
 yes
UGT1A
7
 yes
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
1647
Sourcing

Sourcing

Vendor/AggregatorIDURL
AA Blocks
AA0038VE
https://www.aablocks.com/goods/Goods/detail?id=AA0038VE
AK Scientific, Inc. (AKSCI)
6135AA
http://www.aksci.com/item_detail.php?cat=6135AA
Aaron Chemicals
AR0039N6
http://www.aaronchem.com/133865-89-1
Aceschem
ACF023692
https://www.aceschem.com/catalog/133865-89-1.html
Achemo Scientific Limited
AC-74101
http://www.achemo.com/search/?Keyword= 133865-89-1
Achemtek
0102-020052
http://www.achemtek.com/133865-89-1
Adooq BioScience
A13294
https://www.adooq.com/safinamide.html
Alsachim
1719
http://www.alsachim.com/product-C2493-glo.bal-view.html
Ambeed
A189271
https://www.ambeed.com/products/133865-89-1.html
Annker Organics
P111001
http://www.annker.com/detailproe.php?id=10
Anward
ANW-58666
http://www.anward.com/pro_result/45117
ApexBio Technology
A3784
http://www.apexbt.com/safinamide.html
Aurora Fine Chemicals LLC
A24.076.620
http://online.aurorafinechemicals.com/info?ID=A24.076.620
Aurum Pharmatech LLC
W-5197
http://www.Aurumpharmatech.com/Product/ProductDetails/W_5197
AvaChem Scientific
6759
https://www.avachem.com/productSearch.asp?6759
BLD Pharm
BD150732
http://www.bldpharm.com/products/133865-89-1.html
BioChemPartner
BCP12082
http://www.biochempartner.com/133865-89-1-BCP12082
BioSynth
J-506604
https://www.biosynth.com/en/products/all-products/products/J-506604.html
Boerchem
BC224413
http://www.boerchem.com/?product_37818.html
CSNpharm
CSN11880
https://www.csnpharm.com/products/safinamide.html
Chem Scene
CS-0556
http://www.chemscene.com/133865-89-1.html
ChemMol
44007195
http://www.chemmol.com/chemmol/44007195.html
ChemMol
99041292
http://www.chemmol.com/chemmol/99041292.html
Chemspace
CSSB00016989084
https://chem-space.com/CSSB00016989084
DC Chemicals
DC4134
http://www.dcchemicals.com/product_show-Safinamide.html
Excenen
EX-A2759
https://www.excenen.com/searchresultlist.php?id=133865-89-1
Hairui
HR108800
http://www.hairuichem.com/en/product/133865-89-1.html
Lab Network
LN01343308
https://labnetwork.com/frontend-app/p/#!/moleculedetails/LN01343308
Matrix Scientific
198643
https://www.matrixscientific.com/198643.html
MedChem Express
HY-70057
https://www.medchemexpress.com/Safinamide.html
MuseChem
I001294
https://www.musechem.com/product/I001294.html
Renno Tech
RL01540
http://www.rennotech.com/product_show.asp?id=1789
Smolecule
S542288
http://www.smolecule.com/products/s542288
Synblock Inc
SB16691
http://www.synblock.com/product/133865-89-1.html
TCI (Tokyo Chemical Industry)
S0935
http://www.tcichemicals.com/eshop/en/us/commodity/S0935/index.html
THE BioTek
bt-281161
https://www.thebiotek.com/product/inhibitors/bt-281161
Yuhao Chemical
LL2156
http://www.chemyuhao.com/133865-89-1.html
abcr GmbH
AB506034
http://www.abcr.com/shop/en/AB506034
iChemical
EBD31483
http://www.ichemical.com/products/133865-89-1.html?utm_source=PubChem&utm_medium=website&utm_campaign=product%20catalogs
PubMed

PubMed

TitleDatePubMed
Future prospects for the drug treatment of epilepsy.
2001
Safinamide (Newron Pharmaceuticals).
2001 Jun
Novel anticonvulsant medications in development.
2002 Oct
Progress report on new antiepileptic drugs: a summary of the Sixth Eilat Conference (EILAT VI).
2002 Sep
Pressor response to intravenous tyramine in healthy subjects after safinamide, a novel neuroprotectant with selective, reversible monoamine oxidase B inhibition.
2003 Jul-Aug
Safinamide: FCE 26743, NW 1015, PNU 151774, PNU 151774E.
2004
Improvement of motor function in early Parkinson disease by safinamide.
2004 Aug 24
Pharmacokinetics and pharmacodynamics of safinamide, a neuroprotectant with antiparkinsonian and anticonvulsant activity.
2004 Jul
Crystal structures of monoamine oxidase B in complex with four inhibitors of the N-propargylaminoindan class.
2004 Mar 25
Progress report on new antiepileptic drugs: a summary of the Seventh Eilat Conference (EILAT VII).
2004 Sep-Oct
Voltage gated ion channels: targets for anticonvulsant drugs.
2005
Bioassay of safinamide in biological fluids of humans and various animal species.
2006
New pharmacologic horizons in the treatment of Parkinson disease.
2006 Oct 10
Symptom relief in Parkinson disease by safinamide: Biochemical and clinical evidence of efficacy beyond MAO-B inhibition.
2006 Oct 10
Safinamide: from molecular targets to a new anti-Parkinson drug.
2006 Oct 10
Monoamine oxidase-B inhibition in the treatment of Parkinson's disease.
2007 Dec
Safinamide.
2007 Jan
Safinamide for the treatment of Parkinson's disease, epilepsy and restless legs syndrome.
2007 Jul
Structures of human monoamine oxidase B complexes with selective noncovalent inhibitors: safinamide and coumarin analogs.
2007 Nov 15
Solid-phase synthesis and insights into structure-activity relationships of safinamide analogues as potent and selective inhibitors of type B monoamine oxidase.
2007 Oct 4
An expert opinion on safinamide in Parkinson's disease.
2008 Jul
Computational systems analysis of dopamine metabolism.
2008 Jun 18
Third-generation antiepileptic drugs: mechanisms of action, pharmacokinetics and interactions.
2009 Mar-Apr
Recent advances in adjunctive therapy for epilepsy: focus on sodium channel blockers as third-generation antiepileptic drugs.
2010 Apr
The Movement Disorder Society--14th International Congress of Parkinson's Disease and Movement Disorders.
2010 Aug
Superpose3D: a local structural comparison program that allows for user-defined structure representations.
2010 Aug 5
Two polymorphs of safinamide, a selective and reversible inhibitor of monoamine oxidase B.
2010 Jun
Safinamide in the treatment of Parkinson's disease.
2010 Sep
Novel reversible monoamine oxidase A inhibitors: highly potent and selective 3-(1H-pyrrol-3-yl)-2-oxazolidinones.
2011 Dec 8
3-Acetyl-2,5-diaryl-2,3-dihydro-1,3,4-oxadiazoles: a new scaffold for the selective inhibition of monoamine oxidase B.
2011 Sep 22
1,3-Dialkyl-substituted tetrahydropyrimido[1,2-f]purine-2,4-diones as multiple target drugs for the potential treatment of neurodegenerative diseases.
2013 Dec 1
A novel selective LSD1/KDM1A inhibitor epigenetically blocks herpes simplex virus lytic replication and reactivation from latency.
2013 Feb 5
Patents

Patents

US20070093495A1
3

Sample Use Guides

In Vivo Use Guide
Treatment with Xadago (Safinamide) should be started at 50 mg per day. This daily dose may be increased to 100 mg/day on the basis of individual clinical need.
Route of Administration: Oral
In Vitro Use Guide
Safinamide (PNU-151774E) reduces sustained repetitive firing in a use-dependent manner without modifying the first action potential in hippocampal cultured neurons. The inhibition of the currents by PNU-151774E was concentration-related from 10 to 200 μM.
Name Type Language
SAFINAMIDE (R)-ISOMER
Common Name English
PROPANAMIDE, 2-(((4-((3-FLUOROPHENYL)METHOXY)PHENYL)METHYL)AMINO)-, (2R)-
Common Name English
FCE-28073
Code English
Code System Code Type Description
FDA UNII
UYF2QU7LCX
Created by admin on Sat Dec 16 18:37:19 GMT 2023 , Edited by admin on Sat Dec 16 18:37:19 GMT 2023
PRIMARY
PUBCHEM
5487407
Created by admin on Sat Dec 16 18:37:19 GMT 2023 , Edited by admin on Sat Dec 16 18:37:19 GMT 2023
PRIMARY
NIH
NCATS
PRIVACY ACT
ACCESSIBILITY
DISCLAIMER
HHS VULNERABILITY DISCLOSURE
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