Adamas Announces FDA Approval for Second Indication for GOCOVRI® as an Adjunctive Treatment to levodopa/carbidopa in Parkinson’s Disease Patients Experiencing OFF Episodes
- GOCOVRI is now the first and only medication approved to treat OFF and dyskinesia motor complications -
- Adamas to host webcast conference call today at
“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
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
Conference call details
Adamas will host a conference call and webcast today,
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
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
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.
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
Vice President of Corporate Communications
Managing Director, Westwicke