Adamas’ Parkinson’s drug gets US marketing authorisation for second indication
pharmafile | February 2, 2021 | News story | Manufacturing and Production | Adamas Pharmaceuticals, FDA
The FDA has granted marketing authorisation for a second indication for Adamas Pharmaceuticals’ Gocovri (amantadine) extended release capsules.
The drug is now approved as an adjunctive treatment to levodopa and carbidopa in patients with Parkinson’s disease experiencing off-episodes – when the medication’s effects wear off and symptoms recur – 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.
Data from two pivotal, placebo-controlled Phase III 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, the treatment demonstrated sustained efficacy for at least two years in the Phase III, open-label EASE LID-2 study.
Neil F McFarlane, CEO of Adamas, said: “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.
“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.”
Dr Adrian Quartel, Chief Medical Officer at the company, also commented: “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.
“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.”
Darcy Jimenez
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