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 the publication of a new data analysis titled, “Effects of GOCOVRI® (amantadine) extended-release capsules on motor aspects of experiences of daily living in people with Parkinson’s disease and dyskinesia” in the peer-reviewed journal of Neurology and Therapy. The publication highlights a post-hoc data analysis from two placebo-controlled Phase 3 clinical trials, including a total of 196 patients. Results from the analysis were driven primarily by improvements in motor activities important to patients such as freezing, tremor, and getting out of bed/car/deep chair.
“For people living with Parkinson’s disease, motor complications often have a broad impact on daily activities,” said Robert A. Hauser, M.D., M.B.A., Professor of Neurology and Director of the Parkinson’s Disease and Movement Disorders Center at the University of South Florida. “The improvements in patient-perceived disability associated with motor aspects of PD -- such as freezing of gait, tremors, and getting out of bed -- support the use of GOCOVRI as an important treatment option for PD motor complications.”
“This analysis suggests that GOCOVRI may meaningfully reduce the impact of PD motor symptoms on experiences of daily living,” said Adrian Quartel, Chief Medical Officer, Adamas. “The suggestion that GOCOVRI may impact gait freezing is a particularly interesting finding because freezing appears to be separate from the disease’s primary motor symptoms and is a noted unmet need in the treatment of Parkinson’s.”
In two randomized Phase 3 trials (EASE LID and EASE LID 3), GOCOVRI or placebo was administered for at least 12 weeks to a total of 196 people with Parkinson’s, and the treatment impact of GOCOVRI on dyskinesia was assessed using the Unified Dyskinesia Rating Scale (UDysRS). In this post-hoc analysis, the treatment impact of GOCOVRI on patient-reported motor experiences of daily living was assessed using Part II of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).
At week 12, participants treated with GOCOVRI reported statistically significant improvements in motor control for daily activities compared to placebo (least-squares mean changes from baseline of –3.4 points for GOCOVRI and –1.4 for placebo). The overall treatment difference with GOCOVRI was driven primarily by statistically significant improvements in items related to freezing, tremor, and getting out of bed/car/deep chair. For patients who reported at least mild scores (≥2, problematic) for freezing of gait at baseline, 53.8% taking GOCOVRI and 17.1% taking placebo improved to a nonproblematic score of 0 (none) or 1 (slight) at week 12. For those reporting at least a mild score for tremors at baseline, 66.7% taking GOCOVRI and 35.9% taking placebo improved to a nonproblematic score at week 12. Limitations of this exploratory analysis include the post-hoc nature of the component analysis and insufficient presence of disability for several items at baseline that may affect the ability to show response.
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, referred to as OFF episodes between medication doses, that 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.
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.
Vice President of Corporate Communications