The Food and Drug Administration (FDA) has approved Gocovri® (Amantadine; Adamas Pharma) as an add-on treatment to levodopa / carbidopa in patients with Parkinson’s disease (PD) who experience “off” episodes. This new approval is in addition to its indication for dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy with or without concomitant dopaminergic drugs.
The approval was based on data from 2 randomized, double-blind, placebo-controlled Phase 3 studies evaluating the efficacy and safety of Gocovri for the treatment of dyskinesia in 196 patients with Parkinson’s disease. Patients were randomly assigned to receive either Gocovri 274 mg orally or placebo once daily.
The results of both studies showed that the on-time increased significantly without bothersome dyskinesia and the off-time between the start of the study and week 12 decreased significantly in patients treated with Gocovri compared to placebo. Sustained efficacy for at least 2 years was also observed in the Phase 3 EASE-LID-2 study.
“Many PD drugs require a compromise between shortening the off-time and exacerbating levodopa-induced dyskinesia,” said Dr. Adrian Quartel, Adamas Chief Medical Officer. “Gocovri is the first drug approved to reduce both.”
The product is supplied as retard capsules with 68.5 mg and 137 mg strength in bottles of 60 pieces.
1. Adamas announces FDA approval for the second indication for Gocovri® as an add-on treatment to levodopa / carbidopa in Parkinson’s patients with episodes. [press release]. Emeryville, CA: Adamas Pharmaceuticals, Inc .; February 1, 2021.
2. Gocovri® [package insert]. Emeryville, CA: Adamas Pharma; 2021.
This article originally appeared on MPR
Movement Disorders Treatments for Parkinson’s Disease