Adamas Announces Publication of the Two-Year Phase 3 Open-Label EASE LID 2 Trial of GOCOVRI® for Dyskinesia in Patients with Parkinson’s Disease
- Final results reported from the longest-running clinical trial of an amantadine product in Parkinson’s disease
- Patients taking GOCOVRI experienced long-term reductions in both dyskinesia and OFF time sustained for at least two years
EMERYVILLE, Calif., Feb. 11, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS) a company dedicated to developing and delivering medicines that make a clinically meaningful difference for people affected by neurological diseases, today announced the publication of final results from a two-year open-label study in Parkinson’s disease (PD) that demonstrated a sustained improvement in levodopa-induced dyskinesia (LID) among patients using GOCOVRI® (amantadine) extended-release capsules.
The trial enrolled 223 patients, and results demonstrated that the treatment effect of GOCOVRI on motor complications (dyskinesia and OFF), as measured by the Movement Disorder Society‐Unified Parkinson’s Disease Rating Scale (MDS‐UPDRS), Part IV, was maintained for at least two years. This effect was seen in all subgroups, including those who continued treatment from prior double-blind trials, from placebo or amantadine immediate release (IR), as well as a subgroup of patients with dyskinesia receiving deep brain stimulation (DBS) treatment.
Published online in the Journal of Parkinson’s Disease, the new paper titled “EASE LID 2: A 2-year open-label trial of GOCOVRI (amantadine) extended release for dyskinesia in Parkinson’s disease,” shares results from the 223-participant study (mean PD duration, 11.7 years; mean levodopa use, 9.3 years). The EASE LID 2 study was designed to reflect real-world treatment conditions by including patients with DBS implants and those switching from amantadine IR, while also allowing study physicians to adjust patient’s other PD medications as needed during the study.
“As the longest-running amantadine study to date, this open-label trial suggests GOCOVRI may provide sustained improvement in both dyskinesia and OFF to a wide cohort of patients with Parkinson’s disease living with motor complications,” said Dr. Caroline Tanner, Professor, Dept. of Neurology at University of California, San Francisco. “These results expand not only our knowledge of GOCOVRI efficacy but also of its long-term safety in these patients.”
“These newly published results suggest that GOCOVRI may reduce dyskinesia and OFF as far out as 100 weeks, providing sustained benefits to patients with levodopa-induced dyskinesia. Given the chronic nature of Parkinson’s disease, both patients and physicians seek treatments that are effective long-term,” said Jean Hubble, MD, Vice President of Medical Affairs for Adamas. “This study further demonstrates that the only FDA-approved medicine for dyskinesia may help people with PD who are struggling to manage these levodopa-related motor complications over this long period of time.”
Overall the median treatment duration for trial participants was 1.9 years. In total, 13.9% discontinued the study because of adverse events considered to be related to GOCOVRI. All patients who received at least one dose of GOCOVRI were included in the safety analyses, which demonstrated findings broadly consistent with the phase III trials and product labeling. Common adverse events were falls, hallucinations, peripheral edemas, constipation and urinary tract infections.
Full open access study: “EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson’s Disease”
Published in the Journal of Parkinson’s Disease, online in pre-press mode ahead of publication of the issue.
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.
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.
About Adamas Pharmaceuticals, Inc.
At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies that 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 November 7, 2019, 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.
Managing Director, Westwicke
Vice President of Corporate Communications