Adamas announced that the Food and Drug Administration (FDA) has approved Gocovri (amantadine) extended-release capsules for the treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Gocovri, previously known as ADS-5102, is the first drug FDA-approved for this indication.
The safety and efficacy of Gocovri was seen in two Phase 3 controlled trials in Parkinson’s disease patients with dyskinesia. In Study 1, Gocovri-treated patients had statistically significant and clinically relevant reductions in dyskinesia as per the Unified Dyskinesia Rating Scale (UDysRS) total score vs. placebo at Week 12 (37% vs. 12%). In Study 2, Gocovri-treated patients had a 46% reduction in UDysRS vs. 16% in placebo arm. For both studies, treatment with Gocovri increased functional time daily (ON time without troublesome dyskinesia) for patients at Week 12 (3.6 hours and 4.0 hours, respectively) vs. placebo (0.8 hour and 2.1 hours, respectively).
Rajesh Pahwa, MD, Professor of Neurology at the Kansas Medical Center, added, “Notably, Gocovri is the first Parkinson’s disease medicine proven in controlled trials to reduce both dyskinesia and OFF time in Parkinson’s disease patients receiving levodopa.”
Amantadine is a weak, uncompetitive antagonist of the NMDA receptor. It is thought to work by decreasing the intensity and duration of motor complications by selectively inhibiting overactive NMDA-glutamate receptors.
Gocovri will be available as 68.5mg and 137mg strength extended-release capsules in 60-count bottles. It is anticipated to launch in the 4th quarter.
For more information call (844) 462-6874 or visit Gocovri.com.