EMERYVILLE, Calif., July 15, 2020 (GLOBE NEWSWIRE) — 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 its presentation of a new post-hoc pivotal trial data analysis at the American Academy of Neurology (AAN) Science Highlights Platform showing GOCOVRI decreasing dyskinesia and OFF time for people with Parkinson’s Disease (PD) using GOCOVRI® (amantadine) extended release capsules. GOCOVRI is indicated for the treatment of dyskinesia in people with Parkinson’s disease receiving levodopa-based therapy. The abstract and poster presentation are available on the 2020 AAN Science Highlights Platform.
In this pooled retrospective data analysis, the subset of patients who experienced more than 2.5 hours of OFF time and at least an hour of troublesome dyskinesia a day (101 patients out of total 198 enrolled in clinical trials) were evaluated which showed an improvement of 3.4 hours per day in good ON time on GOCOVRI, compared to placebo. This improvement in good ON time was due to a reduction in the number of hours spent in OFF as well as the hours spent ON with troublesome dyskinesia. In addition to increasing good ON time, patient-reported assessments showed GOCOVRI demonstrated significant improvements in the impact of their symptoms on daily activities and provided more continuous ON time without interruptions from OFF and dyskinesia episodes.
“This presentation aims to provide additional insights on the effect of GOCOVRI in reducing OFF time for patients with Parkinson’s disease,” said Robert A. Hauser MD, MBA, Professor of Neurology, Director, USF Parkinson’s Disease and Movement Disorders Center Parkinson Foundation Center of Excellence, and lead author of the presentation. “For clinicians seeking to improve management of OFF and dyskinesia for patients without adjusting levodopa doses, these results suggest GOCOVRI could be an important treatment option.”
“It is our hope at Adamas that patients will not have to make the difficult decision between reducing OFF time or troublesome dyskinesia,” said Jean Hubble MD, Vice President, Medical Affairs at Adamas. “I am encouraged these results show GOCOVRI can lead to increased good ON time, giving patients the opportunity to spend time with family and friends with fewer disruptions and more sustained good ON time.”
The reduction of OFF was measured as a secondary outcome in the Phase 3 trials for GOCOVRI. Recent OFF trials typically require participants to experience 2-3 hours a day of OFF time at baseline, therefore the subset of patients in this post-hoc study evaluated those who had at least 2.5 hours of OFF time a day.
Presentation details are as follows:
Title: GOCOVRI reduces disruptive motor episodes and improves function in Parkinson’s disease patients with OFF episodes and dyskinesia: Analysis of phase 3 trial data
Lead Author: Robert A. Hauser, MD, MBA, Professor of Neurology, Director, USF Parkinson’s Disease and Movement Disorders Center, Parkinson Foundation Center of Excellence.
About Parkinson’s Disease, Dyskinesia and OFF
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 are likely to experience unpredictable stiffness, rigidity and tremors, referred to as OFF time. 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 time lead to 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. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. 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.
Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas’ commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas’ business in general, see Adamas’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2020, particularly under the caption “Risk Factors.” Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release, except as required by law.
Vice President of Corporate Communications
Managing Director, Westwicke