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 it has been selected as one of five finalists in the UCSF Health Awards 2021 New Therapeutics category. This year’s UCSF Health Awards program, which historically focused on the digital health tech industry, was expanded to include several life science categories. Companies selected as finalists have been evaluated on innovation, impact, and value of their product to improve patient outcomes. Adamas’ new therapeutic is GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine indicated for the treatment of both OFF and dyskinesia in patients with Parkinson’s disease.
“Adamas developed GOCOVRI to make everyday life significantly better for people with Parkinson’s disease,” said Neil F. McFarlane, Chief Executive Officer. “It is, therefore, an honor to be selected as a finalist in a category recognizing the real impact innovative therapeutics can have on patients. I’d like to thank the Adamas team for their contributions which have enabled this recognition.”
As Parkinson’s disease progresses, over 50% of people with Parkinson’s disease (PWP) who have been taking levodopa for five years begin to experience an increase in OFF episodes (including stiffness, rigidity, and tremors occurring between medication doses), dyskinesia (sudden uncontrolled movements) or both. This increase in OFF and dyskinesia affects GOOD ON time when PWPs have good movement control. By ten years, up to 100% of PWP experience these symptoms which reduce the amount of GOOD ON time they have and creates a significant burden on PWP and their families. OFF and dyskinesia affect patients’ ability to perform basic tasks such as walking, dressing, eating, balance, participating in hobbies, and communicating. This reduction in GOOD ON time can be isolating, affecting social interactions and emotional well-being.
Adamas developed GOCOVRI, which 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. GOCOVRI is a major innovation for the management of these symptoms. Its unique release formulation is taken once daily at bedtime, providing 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 when patients need it most. This unique ability of GOCOVRI to decrease both ends of the motor complication spectrum changes the treatment paradigm by allowing physicians to treat patients without the need to trade increased OFF time for reduced dyskinesia or vice versa.
For more information about GOCOVRI, please visit www.GOCOVRI.com.
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.
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.
Vice President of Corporate Communications