Adamas Pharma (ADMS) Announces FDA Approval for Second Indication for GOCOVRI as Adjunctive Treatment to levodopa/carbidopa in Parkinson’s Disease Patients Experiencing OFF Episodes
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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.
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