Gocovri receives FDA approval for second indication in Parkinson’s disease
The FDA approved Gocovri extended-release tablets for patients with Parkinson’s disease, marking the product’s second indication in the disease, according to a press release from Adamas Pharmaceuticals, the drug’s manufacturer.
Gocovri (amantadine, Adamas Pharmaceuticals) is now approved as an adjunctive treatment to levodopa/carbidopa in patients with PD who are experiencing off episodes. The drug first received approval for the management of dyskinesia in patients with PD being treated with levodopa-based therapy with or without concomitant dopaminergic agents, according to the release.
Data from two placebo-controlled phase 3 trials demonstrated that amantadine significantly decreased off time as well as dyskinesia in patients with PD, providing a “clinically meaningful increase in good on time” for patients taking a levodopa-based medication. Additionally, the phase 3, open-label EASE LID-2 study demonstrated that amantadine provided sustained efficacy for at least 2 years.
“The extensive clinical trial evidence for [amantadine] supports its unique ability to reduce off episodes and dyskinesia in people with [PD] who are on levodopa/carbidopa therapy,” Adrian Quartel, MD, chief medical officer of Adamas Pharmaceuticals, said in the release. “Many PD medications necessitate a trade-off between reducing off time and exacerbating levodopa-induced dyskinesia. [Amantadine] is the first medication approved to reduce both.”
- Adamas. Adamas announces FDA approval for second indication for Gocovri as an adjunctive treatment to levodopa/carbidopa for Parkinson’s disease patients experiencing off episodes. Available at: https://ir.adamaspharma.com/news-releases/news-release-details/adamas-announces-fda-approval-second-indication-gocovrir. Accessed Feb. 2, 2021.