-- Patients enrolled in the pivotal trials increased daily ON time without dyskinesia by 2.9 hours with GOCOVRI compared to placebo, through the reduction of both OFF time and dyskinesia -
-- GOCOVRI is the first and only therapy for the treatment of OFF and/or dyskinesia for patients with Parkinson's disease on levodopa-based therapy –
Adamas Pharmaceuticals, Inc. ADMS, a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the publication of an article entitled "Amantadine ER (Gocovri®) significantly increases ON time without any dyskinesia: Pooled analyses from pivotal studies in Parkinson's disease" in the peer-reviewed journal Frontiers in Neurology. GOCOVRI® (amantadine) extended release capsules is the first and only medicine approved as a treatment both for dyskinesia in patients with Parkinson's disease (PD) receiving levodopa-based therapy and as an adjunctive treatment to levodopa/carbidopa in patients with PD experiencing OFF episodes.
The publication examined data from two pivotal, placebo-controlled Phase 3 clinical studies evaluating a total of 196 patients. The results demonstrated that treatment with GOCOVRI more than doubled the daily time patients spent ON without any dyskinesia (whether troublesome or non-troublesome), from 3.9 hours a day at baseline to 8.4 hours at Week 12. Compared to placebo, those treated with GOCOVRI experienced an additional 2.9 hours ON time without dyskinesia, an increase driven by a reduction in both OFF time and dyskinesia. Typically, PD clinical trials for the treatment of motor complications differentiate dyskinesia into ‘troublesome' and ‘non- troublesome' categories. This analysis is unique in evaluating treatment impact by measuring the increase in ON time without any dyskinesia. GOCOVRI-related adverse events were consistent with the known safety profile of amantadine.
"Patients prefer to experience ON time without any dyskinesia, so balancing the need for levodopa-based treatment to reduce OFF time that comes with a risk of increased dyskinesia is a challenge for patient care in Parkinson's disease," said Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson's Disease and Movement Disorders Center at the University of South Florida. "These results expand the knowledge of GOCOVRI's efficacy as an adjunctive treatment to levodopa to address both motor complications."
"This publication highlights GOCOVRI's ability to improve ON time with no dyskinesia – which can make a significant impact on better movement control for someone living with PD motor complications," said Adrian Quartel, M.D., Chief Medical Officer, Adamas. "As the only treatment that addresses both ends of the spectrum in PD motor complications, we are proud to publish data that continue to support GOCOVRI as a treatment option that may help people with Parkinson's increase good movement throughout the day."
This publication analyzed self-reported diary data from pivotal trials, where participants recorded their predominant motor state every 30 minutes for two days prior to each clinic visit. These diary recordings may not be reflective of their typical daily or weekly experience.
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 a considerable impact on patients' lives.
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
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.
The most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and, orthostatic hypotension.
Please see full Prescribing Information for additional important safety information at https://www.gocovri.com/assets/pdfs/Gocovri_Prescribing_Information.pdf.
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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