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In PD patients taking levodopa,

Dyskinesia can occur at any point during the treatment continuum1-4

7 to 12 months

8% of patients develop dyskinesia as early as 7 to 12 months


2 years

26% of patients develop dyskinesia within 2 years


4 to 6 years

~40% of patients develop dyskinesia within 4 to 6 years


10 years

~90% of all patients develop dyskinesia by year 10

Motor complications resulting from levodopa therapy affect about 400,000 PD patients in the United States, with dyskinesia occurring in ~150,000 to ~200,000 patients.1-4

Balancing scales

Achieving good movement control is a balancing act that often involves choosing between treating dyskinesia and OFF5

Physicians report unsatisfactory control of dyskinesia in nearly half of their PD patients6

Based on baseline demographic data from a Phase 3 clinical trial of GOCOVRI,

Dyskinesia can impact patients’ activities of daily living (ADLs)

Percentage of patients reporting mild to moderate impairment of each ADL due to dyskinesia7

Impact of dyskinesia on activities of daily living (ADLs)

Based upon baseline data (from the Unified Dyskinesia Rating Scale Part 1B) at entry into a clinical trial for dyskinesia. Each question rated on a scale of 0 (normal) to 4 (severe) that best describes how dyskinesia affects these activities most of the time. A small percentage of subjects (range: 0% to 6%) reported severe impairment of specific ADLs at baseline.7

THE BENEFITS OF LEVODOPA ARE OFTEN LIMITED by the development of motor complications

  • Chronic use of dopamine replacement, as well as disease progression, are often associated with dyskinesia and motor fluctuations5
  • These complications are associated with higher daily levodopa dose but not necessarily duration of therapy5
  • Current strategies to manage these complications include
    • Adjustments to levodopa dosing, including decreasing and/or fractionating levodopa doses, often leading to increased OFF time6
    • Addition of other dopaminergic treatments that can compromise effective control of PD symptoms and dyskinesia6
Positive correlation of levodopa dose and dyskinesia in balancing treating dyskinesia and OFF

A different approach to managing dyskinesia is needed that helps to address the trade-offs of current management strategies

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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™ (amantadine) 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.

Drug Interactions

Other Anticholinergic Drugs: The dose of GOCOVRI should be reduced if atropine-like effects are observed.

Drugs Affecting Urinary pH: The pH of the urine has been reported to influence the excretion rate of amantadine. Monitor for efficacy or adverse reactions under conditions that alter the urine pH.

Alcohol: Concomitant use with alcohol is not recommended, as it may increase the potential for CNS effects such as dizziness, confusion, lightheadedness, 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.

References: 1. Ahlskog JE, Muenter MD. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord. 2001;16(3):448-458. 2. Kittle G. Parkinson’s disease: What you and your family should know. National Parkinson Foundation website. http://www.parkinson.org/sites/default/files/WhatYouAndYourFamilyShouldKnow.pdf. Accessed September 26, 2017. 3. Cilia R, Akpalu A, Sarfo FS, et al. The modern pre-levodopa era of Parkinson’s disease: insights into motor complications from sub-Saharan Africa. Brain. 2014;137:2731-2742. 4. Schrag A, Quinn N. Dyskinesias and motor fluctuations in Parkinson’s disease. Brain. 2000;123(11):2297-2305. 5. Brooks DJ. Optimizing levodopa therapy for Parkinson’s disease with levodopa/carbidopa/entacapone: implications from a clinical and patient perspective. Neuropsychiatr Dis Trea. 2008:4(1):39-47. 6. Müller T, Woitalla D, Russ H, at al. Prevalence and treatment strategies of dyskinesia in patients with Parkinson’s disease. J Neural Transm. 2007;114:1023-1026. 7. Pahwa R, Tanner CM, Hauser RA, et al. ADS-5102 (amantadine HCl) extended-release capsules improves activities of daily living in Parkinson’s disease patients by reducing levodopa-induced dyskinesia: a post-hoc analysis from the phase 3 EASE LID study. Poster presented at: the 4th World Parkinson Congress; September 23-26, 2016; Portland, Oregon.