Adamas Announces Two Presentations for the American Academy of Neurology 73rd Annual Meeting
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) announced the presentation of two posters at the American Academy of Neurology's 73rd Annual Meeting. One poster focuses on GOCOVRI® (amantadine), the first FDA-approved treatment for dyskinesia in Parkinson's patients on levodopa therapy, addressing both dyskinesia and OFF episodes. The second poster presents survey results on the impact of dyskinesia in Parkinson's disease. The presentations highlight GOCOVRI's unique clinical profile and will be available for viewing from April 17 - 22, 2021.
- First FDA-approved medicine for treating both OFF episodes and dyskinesia in Parkinson's patients.
- Presentation of pivotal trial data supporting GOCOVRI's efficacy in increasing ON time without dyskinesia.
- None.
Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced two posters will be presented at the American Academy of Neurology (AAN) 73rd Annual Meeting. One of the presentations will focus on GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes. The second presentation will feature a survey exploring the impact of dyskinesia and OFF time in people living with PD.
“Data presented at this year’s AAN Annual Meeting highlight the widespread prevalence of motor complications and associated negative social and emotional impacts on people with Parkinson’s and their care partners and also supports GOCOVRI’s unique clinical profile to treat both OFF and dyskinesia motor complications in Parkinson’s disease,” said Adrian Quartel, M.D., Chief Medical Officer. “We will present new data analyses of our pivotal trials evaluating the treatment impact of GOCOVRI in increasing ON time without any dyskinesia. As the only medication approved to treat OFF and dyskinesia, GOCOVRI may be an appropriate treatment option for people with PD experiencing either end of the spectrum of levodopa-related motor complications (OFF or dyskinesia) or both.”
The posters will be available for on-demand viewing the duration of the virtual meeting, April 17 – 22, 2021 from 7:00 am – 5:00 pm EDT. Poster details as follows:
GOCOVRI poster presentation
Title: ADS-5102 significantly increases ON time without dyskinesia: Pooled patient diary analyses from Parkinson’s disease pivotal trials
Session name: P14: Clinical Trials, Surveys, and Studies in Movement Disorders
Lead author: Robert A. Hauser, M.D., University of South Florida
Program number: P14.128
Disease state poster presentation
Title: Evaluating the impact of levodopa-induced dyskinesia and OFF time in persons affected by Parkinson’s disease: Results of a PMD Alliance survey
Session name: P14: Clinical Trials, Surveys, and Studies in Movement Disorders
Lead author: Jill Farmer, D.O., M.P.H., Drexel University and the Global Neurosciences Institute
Program number: P14.148
About Parkinson’s disease, OFF and dyskinesia
Parkinson’s disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people taking levodopa-based therapy are likely to experience reemergence or sudden return of stiffness, rigidity and tremors between medication doses, referred to as OFF episodes, which may be unpredictable. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement, and OFF lead to considerable impact on patients’ lives.
About GOCOVRI
GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes.
Taken once daily at bedtime, GOCOVRI provides an initial lag (delayed release) and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day (extended release). Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.
For more information about GOCOVRI, please visit www.GOCOVRI.com.
IMPORTANT SAFETY INFORMATION
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 (>
Please see full Prescribing Information for additional important safety information at https://www.gocovri.com/assets/pdfs/Gocovri_Prescribing_Information.pdf.
About Adamas
At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.
Source: Adamas Pharmaceuticals, Inc.
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