24 August 2017 - Adamas Pharmaceuticals today announced that the U.S. FDA has approved Gocovri (amantadine) extended release capsules for treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.
Gocovri, previously granted orphan drug status by the FDA, is the first and only medicine approved by the FDA for this indication.
Gocovri's positive benefit/safety profile was established in two Phase 3 controlled clinical trials in Parkinson's disease patients with dyskinesia.