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MENU - UTILITY NAVIGATION

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 * Patient Information
 * Important Safety Information
 * Request a Representative
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OPTIONAL LINKS

 * About GOCOVRI
 * Treatment Paradigm
 * Efficacy
 * Safety
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 * Access & Resources
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 * About GOCOVRI
 * Treatment Paradigm
 * Efficacy
 * Safety
 * Dosing/PK
 * Access & Resources
 * Peer Perspectives


MENU - UTILITY NAVIGATION

 * Prescribing Information
 * Patient Information
 * Important Safety Information
 * Request a Representative
 * Prescription Form
 * Patient Website
 * Get Updates
 * Facebook




GO WITH MORE
GOOD ON TIME

Treat dyskinesia and OFF time without compromising on either. GOCOVRI® is the
only medication proven to reduce both in patients with Parkinson's disease for
more GOOD ON time. Just 1 nightly dose can mean all-day coverage.1,2

Request A Rep Peer Perspectives

Kendall, GOCOVRI patient.


HEAR FROM REAL CLINICIANS PRESCRIBING GOCOVRI

Video cover, click to watch interview with Stuart Isaacson, MD, FAAN.

The daily impact of dyskinesia and OFF time

See the challenges real people with Parkinson’s disease face, as well as some
strategies for identifying and managing dyskinesia and OFF time.



"It's my belief that we need to shift the paradigm, to focus on giving patients
GOOD ON time as consistently as possible throughout the day without
disruptions." –Dr. Isaacson

Video cover, click to watch interview with Robert A. Hauser, MD, MBA, FAAN and …

Who is GOCOVRI right for?
Explore 2 case vignettes that represent patients commonly seen in clinical
practice and discover what more GOOD ON time means to them.



"With a better understanding of how dyskinesia and OFF affect patients, we may
be able to make more informed treatment decisions." –Dr. Hauser

Watch More Peer Perspectives


PROVEN RESULTS IN SHORT-TERM STUDIES AND EVALUATED IN A LONG-TERM OLE STUDY

GOCOVRI was studied in a 12-week Phase 3 trial, a 24-week Phase 3 trial, and a
long-term OLE study.1,3

View Study Results


1 NIGHTLY DOSE FOR ALL-DAY MEDICATION COVERAGE

GOCOVRI is formulated to release slowly while your patients sleep and gradually
increases plasma concentrations until the morning.2

See PK Data




GET GOING WITH GOCOVRI

With a high claims approval rate, it's easy to get your patients started with
GOCOVRI Onboard®.

Learn More


WHY CONSIDER GOCOVRI?

With GOCOVRI, you don’t have to accept a trade-off between dyskinesia and OFF
time. Take a closer look at how GOCOVRI works to treat both dyskinesia and OFF
time in patients like yours.

Treatment Paradigm


GET CLINICAL INFORMATION ON GOCOVRI

Get the latest news and updates about GOCOVRI®, learn about upcoming events, and
more.

Connect

Back to top


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: OLE, open-label extension; PK, pharmacokinetic.

References: 1. GOCOVRI® (amantadine). Prescribing Information. Adamas Pharma
LLC. 2. Hauser RA, Pahwa R, Wargin WA, et al. Pharmacokinetics of ADS-5102
(amantadine) extended release capsules administered once daily at bedtime for
the treatment of dyskinesia. Clin Pharmacokinet. 2019;58(1):77-88.
doi:10.1007/s40262-018-0663-4 3. 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.

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Breakdown of Results From Individual Pivotal Studies

41% IMPROVEMENT in dyskinesia (UDysRS from baseline)3,7

PRIMARY ENDPOINT

STUDY 1

GOCOVRI® demonstrated a 15.9-point reduction (baseline: 40.9) in the UDysRS
total score vs. an 8.0 reduction with placebo (baseline: 38.5) through Week 12
(P = 0.0009)3,5

STUDY 2

GOCOVRI® demonstrated a 20.7-point reduction (baseline: 40.2) in the UDysRS
total score vs. a 6.3 reduction with placebo (baseline: 41.2) through Week 12 (P
< 0.0001)3,5

21% REDUCTION in OFF time (from baseline)3,7

SECONDARY ENDPOINT

STUDY 1

GOCOVRI® decreased OFF time by 0.6 hours (baseline: 3.2) vs. an increase of 0.3
hours with placebo (baseline: 3.0) (P = 0.0171)3,5

STUDY 2

GOCOVRI® decreased OFF time by 0.5 hours (baseline: 2.6) vs. an increase of 0.6
hours with placebo (baseline: 2.0) (P = 0.0199)3,5

3.8-HOUR INCREASE in GOOD ON time (from baseline)3,7

SECONDARY ENDPOINT

STUDY 1

GOCOVRI® increased GOOD ON time by 3.6 hours (baseline: 8.3) vs. 0.8 hours with
placebo (baseline: 8.5) (P < 0.0001)3,5

STUDY 2

GOCOVRI® increased GOOD ON time by 4.0 hours (baseline: 8.8) vs. 2.1 hours with
placebo (baseline: 7.8) (P = 0.0168)3,5

Diary States Summary

Secondary efficacy endpoints based on patient diary data7,8

Results for dyskinesia, OFF time, and GOOD ON time, respectively; GOCOVRI® (vs.
placebo)

STUDY 1

Baseline hours: 4.7 (vs. 4.5), 3.2 (vs. 3.0), and 8.3 (vs. 8.5)

Week 12 hours: 1.5 (vs. 3.0), 2.6 (vs. 3.4), and 12.0 (vs. 9.2)

STUDY 2

Baseline hours: 4.7 (vs. 6.0), 2.6 (vs. 2.0), and 8.8 (vs. 7.8)

Week 12 hours: 1.4 (vs. 3.2), 2.0 (vs. 2.7), and 12.5 (vs. 10.0)

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