Free 4-week trial

GOCOVRI® was evaluated in 2 clinical trials

The efficacy and safety of GOCOVRI® 274 mg were evaluated in two Phase 3, randomized, placebo-controlled trials1-3:

  •  Study 1, a 24-week study, was conducted in 121 PD patients with dyskinesia (GOCOVRI® [n = 63], placebo [n = 58])
  •  Study 2, a 12-week study, was conducted in 75 patients with dyskinesia (GOCOVRI® [n = 37], placebo [n = 38])
  •  The primary efficacy endpoint was change in UDysRS total score from baseline to Week 12. Key secondary endpoints from a PD home diary: changes from baseline to Week 12 in ON time without troublesome dyskinesia, ON time with troublesome dyskinesia, and OFF time
  •  Each study was independently positive

Dyskinesia

Off time

Functional time

Diary states summary

Less dyskinesia achieved without adjustments to levodopa

GOCOVRI® demonstrated a significant and clinically relevant placebo-adjusted reduction of 10.1 in
UDysRS total score through Week 12 (pooled Study 1 and Study 2 primary endpoint results)1,2

GOCOVRI Pooled Treatment Groups: Unified Dyskinesia Rating Scale (UDysRS) Total Score
  • UDysRS = Unified Dyskinesia Rating Scale

Less off time achieved without adjustments to levodopa

GOCOVRI® decreased OFF time by 1 hour a day (placebo-adjusted) through Week 12 (pooled Study 1 and Study 2 key secondary endpoint results)1,3

GOCOVRI Pooled Treatment Groups: OFF Time
  • Derived from PD home diary.

More functional time achieved without adjustments to levodopa

In Study 1 and Study 2, functional time (ON time without troublesome dyskinesia) increased by 3.6 and 4.0 hours, respectively. In the pooled analysis, GOCOVRI® provided a gain of up to 3.8 hours in functional time1-3

GOCOVRI Pooled Treatment Groups: ON Time Without Troublesome Dyskinesia
  • Derived from PD home diary.

Less dyskinesia and less off time led to more functional time throughout the day

Based on pooled diary state data from Study 1 and Study 2 (secondary endpoints), GOCOVRI® decreased troublesome dyskinesia and OFF time, leading to significantly more functional time (ON time without troublesome dyskinesia) throughout the day3

GOCOVRI Diary States Summary GOCOVRI Diary States Summary GOCOVRI Diary States Summary GOCOVRI Diary States Summary green1 green2 green3 green4 grey1 grey2 grey3 grey4 yellow1 yellow2 yellow3 yellow4
  • UDysRS = Unified Dyskinesia Rating Scale.

Dyskinesia

Less dyskinesia achieved without adjustments to levodopa

GOCOVRI® demonstrated a significant and clinically relevant placebo-adjusted reduction of 10.1 in UDysRS total score through Week 12 (pooled Study 1 and Study 2 primary endpoint results)1,2

GOCOVRI Pooled Treatment Groups: Unified Dyskinesia Rating Scale (UDysRS) Total Score
  • UDysRS = Unified Dyskinesia Rating Scale

Off time

Less off time achieved without adjustments to levodopa

GOCOVRI® decreased OFF time by 1 hour a day (placebo-adjusted) through Week 12 (pooled Study 1 and Study 2 key secondary endpoint results)1,3

GOCOVRI Pooled Treatment Groups: OFF Time
  • Derived from PD home diary.

Functional time

More functional time achieved without adjustments to levodopa

In Study 1 and Study 2, functional time (ON time without troublesome dyskinesia) increased by 3.6 and 4.0 hours, respectively. In the pooled analysis, GOCOVRI® provided a gain of up to 3.8 hours in functional time1-3

GOCOVRI Pooled Treatment Groups: ON Time Without Troublesome Dyskinesia
  • Derived from PD home diary.

Diary states summary

Less dyskinesia and less off time led to more functional time
throughout the day

Based on pooled diary state data from Study 1 and Study 2 (secondary endpoints), GOCOVRI® decreased troublesome dyskinesia and OFF time, leading to significantly more functional time (ON time without troublesome dyskinesia) throughout the day3

GOCOVRI Diary States Summary GOCOVRI Diary States Summary GOCOVRI Diary States Summary GOCOVRI Diary States Summary green1 green2 green3 green4 grey1 grey2 grey3 grey4 yellow1 yellow2 yellow3 yellow4
  • UDysRS = Unified Dyskinesia Rating Scale.

See the difference Gocovri® makes

Watch Kendall's testimonial—a real patient living with PD dyskinesia

  • This is one patient's experience with GOCOVRI®. Results may vary.

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Important Safety Information

Indication

GOCOVRI® (amantadine) extended release capsules is indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

Contraindications

GOCOVRI is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2.

Warnings and Precautions

Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with Parkinson’s disease medications have reported falling asleep during activities of daily living. If a patient develops daytime sleepiness during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), GOCOVRI should ordinarily be discontinued or the patient should be advised to avoid potentially dangerous activities.

Suicidality and Depression: Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with GOCOVRI in patients with a history of suicidality or depression.

Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.

Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose.

Withdrawal-Emergent Hyperpyrexia and Confusion: Rapid dose reduction or abrupt discontinuation of GOCOVRI, may cause an increase in the symptoms of Parkinson’s disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. Avoid sudden discontinuation of GOCOVRI.

Impulse Control/Compulsive Behaviors: Patients may experience urges (e.g. gambling, sexual, money spending, binge eating) and the inability to control them. It is important for prescribers to ask patients or their caregivers about the development of new or increased urges. Consider dose reduction or stopping medications.

Adverse Reactions

The most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension.

View the full Prescribing Information.

Indication

GOCOVRI® (amantadine) extended release capsules is indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

References: 1. Elmer LW, Juncos JL, Singer C, et al. Pooled analyses of phase III studies of ADS-5102 (amantadine) extended-release capsules for dyskinesia in Parkinson’s disease. CNS Drugs. 2018;32(4):387-398. 2. GOCOVRI® (amantadine) [Prescribing Information]. Emeryville, CA: Adamas Pharma LLC; 2017. 3. Data on File. Adamas Pharma LLC, Emeryville, CA. 4. Pahwa R, Tanner CM, Hauser RA, et al. ADS-5102 (amantadine) extended-release capsules for levodopa-induced dyskinesia in Parkinson’s disease (EASE LID Study): a randomized clinical trial. JAMA Neurol. 2017;74(8):941-949. 5. Pahwa R, Tanner CM, Hauser RA, et al. Pooled analysis of phase 3 studies of ADS-5102 (amantadine) extended release capsules for levodopa-induced dyskinesia: a detailed review of UDysRS results. Poster presented at: 2017 Annual Meeting of the American Neurological Association; October 15–17, 2017; San Diego, CA. 6. Oertel W, Eggert K, Pahwa R, et al. Randomized, placebo-controlled trial of ADS-5102 (amantadine) extended-release capsules for levodopa-induced dyskinesia in Parkinson’s disease (EASE LID 3). Mov Disord. 2017;32(12):1701-1709. 7. Goetz CG, Nutt JG, Stebbins GT. The Unified Dyskinesia Rating Scale: presentation and clinimetric profile. Mov Disord. 2008;23(16):2398-2403. 8. Hauser R, Pahwa R, Tanner CM, et al. ADS-5102 (amantadine) extended-release capsules for levodopa-induced dyskinesia in Parkinson’s disease (EASE LID 2 study): interim results of an open-label safety study. J Parkinsons Dis. 2017;7(3):511-522.