GOCOVRI

GOCOVRI is an extended-release formulation. The pharmacokinetics of amantadine from 68.5 mg, 137 mg, and 274 mg of GOCOVRI are dose proportional in healthy subjects.

AbsorptionAfter a single dose bedtime administration of GOCOVRI, the median T max for plasma amantadine was around 12 hours (range 6-20 hours). The steady-state concentrations of GOCOVRI were achieved 4 days after the dose initiation. The steady-state total exposures (AUC 0-tau ) were 20-30% higher than after single dose, suggestin...

Overview of Studies The efficacy of GOCOVRI for the treatment of dyskinesia in patients with Parkinson's disease and for the adjunctive treatment to levodopa/carbidopa in patients with Parkinsons's disease experiencing "off" episodes was assessed in two randomized, double-blind, placebo-controlled efficacy trials: Study 1 and Study 2. Key inclusion criteria in both studies included at least 1 hour of troublesome dyskinesia time during the day and at least mild functional impact because of dyskinesia. Study 1 was conducted in 121 (modified Intention to Treat (mITT) population) Parkinson's disea...

The following serious adverse reactions are described in more detail elsewhere in the labeling: Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions ( 5.1 )] Suicidality and Depression [see Warnings and Precautions ( 5.2 )] Hallucinations/Psychotic Behavior [see Warnings and Precautions ( 5.3 )] Dizziness and Orthostatic Hypotension [see Warnings and Precautions ( 5.4 )] Withdrawal-Emergent Hyperpyrexia and Confusion [see Warnings and Precautions ( 5.5 )]...

GOCOVRI is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m 2 ) [see Clinical Pharmacology ( 12.3 )]. GOCOVRI is contraindicated in patients with end-stage renal disease ( 4 )

Falling Asleep During Activities of Daily Living : Advise patients prior to treatment; ordinarily discontinue if occurs ( 5.1 ) Suicidality and Depression : Monitor patients for depressed mood, depression, or suicidal ideation or behavior ( 5.2 ) Hallucinations/Psychotic Behavior: Patients with major psychotic disorder should ordinarily not be treated with GOCOVRI; observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases ( 5.3 ...

7 DRUG INTERACTIONS Other Anticholinergic Drugs: Doses should be reduced if atropine-like effects occur ( 7.1 ) Drugs Affecting Urinary pH: Excretion increases with acidic urine; possible accumulation with urine change towards alkaline ( 7.2 ) Live Attenuated Influenza Vaccines: Not recommended during use ( 7.3 ) Alcohol: Concomitant use not recommended ( 7.4 ) 7.1 Other Anticholinergic Drugs Prod...