FDA approves Gocovri (amantadine extended release tablets) to treat dyskinesia in patients with Parkinson's disease.-Adamas Pharmaceuticals.

Adamas Pharmaceuticals, Inc. announced that the FDA has approved Gocovri (amantadine) extended release capsules (previously ADS-5102) 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 is a high dose 274 mg amantadine (equivalent to 340 mg amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day when dyskinesia occurs. Dyskinesia is a consequence of levodopa-based Parkinson's disease treatment and is characterized by involuntary and non-rhythmic movements that are purposeless and unpredictable, which impact the activities of daily living. Gocovri is expected to be available in the fourth quarter, and formally launched with the full deployment of Adamas's sales force in January 2018.