The Food and Drug Administration (FDA) has approved Gocovri® (amantadine; Adamas Pharma) as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson disease (PD) experiencing “off” episodes. This new approval is in addition to its indication for dyskinesia in patients with PD receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
The approval was based on data from 2 randomized, double-blind, placebo-controlled phase 3 studies that evaluated the efficacy and safety of Gocovri for the treatment of dyskinesia in 196 patients with PD experiencing off episodes. Patients were randomly assigned to receive either Gocovri 274mg orally once daily or placebo.
Results from both studies showed there was a significant increase in “on” time without troublesome dyskinesia, and a significant decrease in “off” time between baseline and week 12 in patients treated with Gocovri, compared with placebo. Sustained efficacy for at least 2 years was also observed in the phase 3 EASE LID-2 study.
“Many PD medications necessitate a trade-off between reducing ‘off’ time and exacerbating levodopa-induced dyskinesia,” said Adrian Quartel, MD, Chief Medical Officer, Adamas. “Gocovri is the first medication approved to reduce both.”
The product is supplied as 68.5mg and 137mg strength extended-release capsules in 60-count bottles.
1. Adamas announces FDA approval for second indication for Gocovri® as an adjunctive treatment to levodopa/carbidopa in Parkinson’s disease patients experiencing off episodes. [press release]. Emeryville, CA: Adamas Pharmaceuticals, Inc.; February 1, 2021.
2. Gocovri® [package insert]. Emeryville, CA: Adamas Pharma; 2021.