Adamas Announces GOCOVRI Presentations at the Upcoming International Parkinson and Movement Disorder Society’s (MDS) Congress

“We are pleased to present several analyses of different published clinical studies to highlight the importance of choosing the appropriate treatment options to address motor complications in Parkinson’s disease. GOCOVRI’s clinical results continue to demonstrate its unique and meaningful treatment impact on both OFF and dyskinesia – including through indirect comparisons with other levodopa-adjunctive treatments and amantadine-based products,” said Adrian Quartel, M.D., Chief Medical Officer, Adamas. “Additionally, in a post-hoc analysis, GOCOVRI as an only/early add-on treatment to levodopa showed reductions of OFF and dyskinesia that were similar to, or greater than, those seen in the overall trial population. Overall, we are pleased to offer patients a non-surgical treatment option that increases their GOOD ON time and doesn’t necessitate a trade-off between treating OFF or dyskinesia.”

One presentation (Poster 446) will highlight pooled data from GOCOVRI pivotal trials to evaluate the efficacy of GOCOVRI as a first/early add-on treatment to levodopa for Parkinson’s disease (PD) motor complications (OFF or dyskinesia). This post-hoc analysis examined two subgroups of patients: 1) those using levodopa as their only medication for PD, and 2) those who developed motor complications and entered the GOCOVRI trials within five years of being diagnosed with PD. The results of this analysis support GOCOVRI as an early adjunctive treatment to levodopa for patients with early motor complications - OFF or dyskinesia.

Two presentations will highlight indirect treatment comparisons between GOCOVRI and other treatment options based on existing published clinical data, that support GOCOVRI as a highly differentiated, cost-effective treatment option:

• Poster 500: In a comparison of efficacy data from pivotal clinical trials for approved levodopa-adjunctive treatments, GOCOVRI and deep brain stimulation (DBS) reduced OFF time and dyskinesia by over 30% relative to placebo. Oral dopaminergic treatments and levodopa/carbidopa intestinal gel (CLIG) reduced OFF time by 15-29% over placebo, with a 12-31% increase in dyskinesia for the oral treatments, and no significant impact on dyskinesia for CLIG.
• Poster 520: The efficacy of GOCOVRI versus other formulations of amantadine were compared through a traditional Indirect Treatment Comparison (ITC) analysis. While GOCOVRI has shown statistically significant reductions in both OFF time, by 36%, and dyskinesia, by 27%, amantadine immediate release (IR) and amantadine IR/extended release (IR/ER) reduced dyskinesia scores by 19% and 13%, respectively. Neither amantadine IR nor amantadine IR/ER demonstrated a significant change in OFF time in randomized, double-blind, clinical trials.

Two additional posters will be presented that support the use of GOCOVRI to manage motor complications and their impact on daily activities in people with PD:

• Poster 395: For patients who may be candidates for device-aided therapies to manage motor complications (DBS, levodopa/carbidopa intestinal gel, or subcutaneous-apomorphine infusion), a post-hoc analysis showed GOCOVRI increased GOOD ON time by ~2.8 hours vs. placebo, with corresponding reductions in OFF time and dyskinesia. These results suggest GOCOVRI should be considered for certain patients who may be otherwise eligible for device-aided therapies.
• Poster 414: This post-hoc analysis of clinical trial data evaluates the collective interference of dyskinesia and OFF across daily activities and experiences for persons with Parkinson’s and shows that GOCOVRI significantly reduced dyskinesia and OFF and their associated impact on these daily activities.

The posters will be available for on-demand viewing beginning September 10, 2021, and available for the duration of the meeting. Details are as follows:

Poster 395: Should amantadine DR/ER be considered prior to device-aided therapies for Parkinson’s disease?
Lead author: Robert A. Hauser, M.D., University of South Florida
Abstract Category: Clinical Trials

Poster 414: Amantadine DR/ER-related reduction in OFF and dyskinesia improved patient-rated interference with activities and social interactions
Lead author: Kelly E. Lyons, Ph.D., University of Kansas Medical Center
Abstract Category: Clinical Trials

Poster 446: Amantadine DR/ER efficacy as early add-on for motor complications in Parkinson’s disease
Lead author: Caroline M. Tanner, M.D., Ph.D., University of California, San Francisco
Abstract Category: Clinical Trials

Poster 500: Indirect treatment comparison of adjunctive treatments for patients with Parkinson’s disease experiencing motor complications
Lead author: Daniel E. Kremens, M.D., J.D., Jefferson University Hospital, Philadelphia, PA
Abstract Category: Pharmacology and Therapy

Poster 520: Analysis of amantadine formulations for OFF and dyskinesia in Parkinson disease
Lead author: Wolfgang Oertel, M.D., Ph.D., University of Marburg, Germany
Abstract Category: Pharmacology and Therapy

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 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 (>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

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.

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