GO with a well-established safety profile

Adverse reactions reported for >5% of patients treated with 274 mg GOCOVRI® in Study 1 and Study 2 (pooled analysis)1

Adverse Reactions (>5%) GOCOVRI® 274 mg
n = 100
%		 PLACEBO
n = 98
%
Psychiatric disorders
Hallucinationa 21 3
Anxietyb 7 3
Insomnia 7 2
Depression/depressed mood 6 1
Nervous system disorders
Dizziness 16 1
Headache 6 4
Gastrointestinal disorders
Dry mouth 16 1
Constipation 13 3
Nausea 8 3
General disorders and administration site conditions
Peripheral edema 16 1
Injury, poisoning, and procedural complications
Fall 13 7
Contusion 6 1
Infections and infestations
Urinary tract infection 10 5
Skin and subcutaneous tissue disorders
Livedo reticularis 6 0
Metabolism and nutrition disorders
Decreased appetite 6 1
Vascular disorders
Orthostatic hypotensionc 13 1
Reproductive system and breast disorders
Benign prostatic hyperplasiad 6 2

aIncludes visual hallucinations and auditory hallucinations.

bIncludes anxiety and generalized anxiety.

cIncludes orthostatic hypotension, postural dizziness, syncope, presyncope, and hypotension.

dThe denominator is all male patients in the safety population randomized to GOCOVRI® (n = 54) or placebo (n = 57).

Other clinically relevant adverse reactions observed at <3% included somnolence, fatigue, suicide ideation or attempt, apathy, delusions, illusions, and paranoia.

If your patient reports any adverse reactions, you should report them to the FDA at 1-800-FDA-1088 or fda.gov/medwatch.

In pivotal trials, most hallucinations were rated as mild to moderate and the majority were fully resolved1-3

POOLED SAFETY DATA

Schema showing hallucinations data from pivotal trials.

Investigator rating:

  • 13 (62%) as mild
  • 6 (29%) as moderate
  • 2 (10%) as severe

Resolution of hallucinations:

  • 18 (86%) fully resolved with discontinuation, interruption, or dose reduction. 3 (14%) did not get resolved but continued on treatment
  • 12 (57%) resolved in ≤2 weeks
  • None required hospitalization or treatment with antipsychotics

The majority of patients with PD are elderly and therefore more likely to have decreased renal function, which may put these patients at greater risk of adverse events. Care should be taken in dose selection; observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.1

Pooled ARs leading to treatment discontinuations1

The overall pooled rate of discontinuation in at least 2% of patients due to adverse reactions for patients treated with placebo was 8% vs. 20% with GOCOVRI®1

Adverse Reactions (≥3%) GOCOVRI® 274 mg
n = 100
% 		PLACEBO
n = 98
%
Summary
Hallucination 8 0
Dry mouth 3 0
Peripheral edema 3 0
Blurred vision 3 0
Postural dizziness and syncope 2 0
Abnormal dreams 2 1
Dysphagia 2 0
Gait disturbance 2 0

In the EASE LID 2 OLE study

The safety profile of GOCOVRI® in this long-term study remained consistent with the pivotal trials4

Adverse events and discontinuations due to adverse events (safety population)a,4

Adverse Events CONTINUING 
GOCOVRI® 
(n = 60) 		PREVIOUS 
PLACEBO 
(n = 78) 		ALL PATIENTS 
(N = 223)
Summary
Any AE 57 (95.0%) 70 (89.7%) 205 (91.9%)
Any SAE 16 (26.7%) 21 (26.9%) 60 (26.9%)
Any leading to study-drug discontinuation or death 12 (20.0%) 21 (26.9%) 49 (22.0%)
By preferred terma
Fall 13 (21.7%) 29 (37.2%) 73 (32.7%)
Hallucination 15 (25.0%) 24 (30.8%) 54 (24.2%)
Visual 14 (23.3%) 24 (30.8%) 52 (23.3%)
Peripheral edema 10 (16.7%) 12 (15.4%) 36 (16.1%)
Constipation 9 (15.0%) 12 (15.4%) 30 (13.5%)
Urinary tract infection 7 (11.7%) 8 (10.3%) 23 (10.3%)
Dizziness 4 (6.7%) 10 (12.8%) 22 (9.9%)
Nausea 7 (11.7%) 8 (10.3%) 22 (9.9%)
Insomnia 8 (13.3%) 5 (6.4%) 21 (9.4%)
Livedo reticularis 6 (10.0%) 5 (6.4%) 20 (9.0%)
ON and OFF phenomenon 7 (11.7%) 4 (5.1%) 18 (8.1%)
Dry mouth 4 (6.7%) 6 (7.7%) 17 (7.6%)

aIncludes all preferred terms with an incidence ≥7.5% among all patients.

  • Discontinuations due to adverse events occurred more frequently among patients initiating GOCOVRI® in this study, compared to those who continued on GOCOVRI® from Phase 3 trials4
  • Discontinuations tended to occur in the first weeks of treatment around dose initiation and titration4
  • No new safety signals were observed in this open-label extension4

How is GOCOVRI formulated?

GOCOVRI simplifies your patients’ dosing regimen with just 1 nightly dose for all-day medication coverage. Learn how GOCOVRI gradually increases plasma concentrations while your patients sleep.

See PK Data

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Important Safety Information

IMPORTANT SAFETY INFORMATION AND INDICATION

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.

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
  • As adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes

It is not known if GOCOVRI is safe and effective in children.

Please see full Prescribing Information and Patient Information.

Abbreviations: AE, adverse event; ARs, adverse reactions; OLE, open-label extension; PD, Parkinson’s disease; PK, pharmacokinetics; SAE, serious adverse event.

References: 1. GOCOVRI® (amantadine). Prescribing Information. Adamas Pharma LLC; 2021. 2. Data on file. Adamas Pharma LLC. 3. 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. doi:10.1007/s40263-018-0498-4 4. Tanner CM, Pahwa R, Hauser RA, et al. EASE LID 2: a 2-year open-label trial of Gocovri (amantadine) extended release for dyskinesia in Parkinson’s disease. J Parkinsons Dis. 2020;10(2):543-558. doi:10.3233/JPD-191841

Important Safety Information

IMPORTANT SAFETY INFORMATION AND INDICATION

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.

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
  • As adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes

It is not known if GOCOVRI is safe and effective in children.

Please see full Prescribing Information and Patient Information.