Adamas Announces FDA Approval for Second Indication for GOCOVRI® as an Adjunctive Treatment to levodopa/carbidopa in Parkinson’s Disease Patients Experiencing OFF Episodes
Adamas Pharmaceuticals (Nasdaq: ADMS) announced FDA marketing authorization for GOCOVRI® (amantadine) extended release capsules, now approved for a second indication: as an adjunctive treatment for Parkinson's disease patients experiencing OFF episodes. This milestone enhances treatment options for over one million U.S. patients with Parkinson's, with GOCOVRI being the first drug approved for both OFF episodes and dyskinesia. The approval results from pivotal Phase 3 trials demonstrating significant efficacy in reducing both OFF time and dyskinesia.
- FDA approval for GOCOVRI as an adjunctive treatment for OFF episodes in Parkinson's disease patients.
- First medication approved to treat both OFF and dyskinesia motor complications in Parkinson's disease.
- Expanded market opportunity potentially more than doubles the patient population GOCOVRI can treat.
- Strong clinical trial data supporting sustained efficacy for at least two years.
- Potential side effects include hallucinations and dizziness, which may limit patient adherence.
- Approval is subject to ongoing monitoring and potential safety concerns.
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 received marketing authorization from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application for GOCOVRI® (amantadine) extended release capsules, gaining a second indication for the product. GOCOVRI is now approved as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing OFF episodes, in addition to its indication for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
“The approval of a second indication for GOCOVRI is a major milestone for patients with Parkinson’s who experience motor complications in their daily lives. GOCOVRI is now the first and only medication approved to treat both OFF and dyskinesia motor complications in Parkinson’s disease,” said Neil F. McFarlane, Chief Executive Officer. “This approval also meaningfully enhances our commercial opportunity by more than doubling the potential number of patients with conditions GOCOVRI is approved to treat. I am very pleased with the performance of our team in executing our growth strategy and look forward to improving access for patients in 2021 and beyond with the expanded label for GOCOVRI.”
Data from two pivotal, placebo-controlled Phase 3 clinical studies showed that treatment with GOCOVRI significantly reduced both OFF time and dyskinesia. This resulted in a clinically meaningful increase in good ON time in patients taking a levodopa-based medication for Parkinson’s disease. Additionally, GOCOVRI demonstrated sustained efficacy for at least two years in the Phase 3, open-label EASE LID-2 study.
“We are delighted in the FDA’s responsiveness to our application to include the clinically meaningful reduction in OFF episodes in the indication statement which provides patients and physicians with accurate and complete information to make appropriate treatment decisions,” said Adrian Quartel, M.D., Chief Medical Officer. “The extensive clinical trial evidence for GOCOVRI supports its unique ability to reduce OFF episodes and dyskinesia in people with Parkinson’s disease who are on levodopa/carbidopa therapy. Many PD medications necessitate a trade-off between reducing OFF time and exacerbating levodopa-induced dyskinesia. GOCOVRI is the first medication approved to reduce both.”
Conference call details
Adamas will host a conference call and webcast today, February 1, 2021, at 4:30 pm ET/1:30 pm PT to discuss the approval of its sNDA for GOCOVRI. The conference call can be accessed by dialing (877) 407-9716 (toll-free) or 201-493-6779 (toll/international) using the conference ID 13715919. The webcast can be accessed live via the Investors section of the Adamas website at http://ir.adamaspharma.com/events-presentations and will be available for replay for approximately 30 days.
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.
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 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
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 (>
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.
Forward-looking statements
Statements contained in this press release regarding matters that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements contained in this press release regarding Adamas’ expectations regarding the potential number of patients with conditions GOCOVRI is approved to treat. 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’ research, clinical, development and 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 5, 2020, particularly under the caption “Risk Factors.” In addition, the impact that the current COVID-19 pandemic is having and will have on demand for GOCOVRI, and the unknown duration and severity of the COVID-19 pandemic, add additional risk and uncertainty to these forward-looking statements. 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.
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