FDA Approves First Treatment for Therapy-Induced Dyskinesia

The US Food and Drug Administration recently approved Gocovri (amantadine) for the treatment of dyskinesia in patients with Parkinson disease who are receiving levodopa-based therapy, with or without concomitant dopaminergic medications. This is the first and only drug approved by the FDA for levodopa-induced dyskinesia.

Gocovri is recommended to be taken once a day at bedtime and is administered at a dose of 274 mg.
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Approval was based on 2 phase 3 controlled clinical trials that included patients with Parkinson disease and dyskinesia. In both studies, patients receiving Gocovri experienced statistically significant reductions in the Unified Dyskinesia Rating Scale and increases in functional time compared with the placebo groups.

Common adverse effects associated with Gocovri included hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension.

In addition, Gocovri includes the following warnings and precautions: falling asleep during daily activities and somnolence, suicidality and depression, hallucinations and psychotic behavior, and impulse control and compulsive behaviors. Patients should be monitored for any adverse reactions after initiating Gocovri, and the harms and benefits should be considered before continuing or discontinuing treatment. The sudden discontinuation of Gocovri can cause withdrawal emergent hyperpyrexia and confusion, and should be avoided if possible.  

—Melissa Weiss

Reference:

Adamas announces FDA approval of GOCOVRI™ as first and only medication for the treatment of dyskinesia in Parkinson's disease patients [press release]. Emeryville, CA: Adamas Pharmaceuticals Inc.; August 24, 2017. http://ir.adamaspharma.com/releasedetail.cfm?ReleaseID=1038209. Accessed August 25, 2017.