The US Food and Drug Administration (FDA) has approved Gocovri™ (extended-release amantadine) for the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease who may or may not be receiving concomitant dopaminergic therapies. This is the first FDA approval for this indication.
The high-dose amantadine (274 mg) is taken at bedtime and continues to release throughout the morning and day when patients might experience levodopa-induced dyskinesia.
“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,” principal investigator Rajesh Pahwa, MD, of the University of Kansas, said in a statement. “Treatment of dyskinesia and OFF time continues to be an unmet need in the medical management of Parkinson’s disease and the approval of GOCOVRI is a major step in that direction.”
As previously reported by Neurology Advisor, amantadine was evaluated in a phase 3, randomized, double-blind, placebo-controlled trial of 121 patients over 24 weeks. Participants who received extended-release amantadine experienced a significant reduction in Unified Dyskinesia Rating Scale scores over the study period compared with those receiving placebo.
The most common adverse events reported in patients taking Gocovri include hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension. In addition, patients and physicians should be aware of increasing somnolence, suicidality and depression, withdrawal-emergent hyperpyrexia and confusion, and compulsive behaviors.
Gocovri is contraindicated in patients with a creatinine clearance <15 mL/min/1.73 m2.
Adamas Pharmaceuticals expects Gocovri to be available in the fourth quarter of 2017.
Adamas Announces FDA Approval of GOCOVRI™ as First and Only Medication for the Treatment of Dyskinesia in Parkinson’s Disease Patients [news release]. Emeryville, CA: Adamas Pharmaceuticals newsroom; August 24, 2017.