General Information

Gocovri is specifically indicated for:

the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications;

as adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes

Gocovri is supplied as an extended release capsule for oral administration. The initial daily dosage is 137 mg; after 1 week, increase to the recommended daily dosage of 274 mg. Administer orally once daily at bedtime. The capsules may be swallowed whole or the contents may be sprinkled on soft food. A lower dosage is recommended for patients with moderate or severe renal impairment.

Mechanism of Action

Gocovri (amantadine) is a weak uncompetitive antagonist of the NMDA receptor. The mechanism by which amantadine exerts efficacy in the treatment of dyskinesia in patients with Parkinson’s disease is unknown. Amantadine has not been shown to possess direct anticholinergic activity in animal studies; however, it exhibits anticholinergic-like side effects such as dry mouth, urinary retention, and constipation in humans. Amantadine may have direct and indirect effects on dopamine neurons; it exerts dopaminergic-like side effects such as hallucinations and dizziness in humans.

Indication 1 - for the treatment of Parkinson's disease dyskinesia

approved August 2017

Clinical Trial Results

The FDA approval of Gocovri was based on two Phase III controlled clinical trials in Parkinson’s disease patients with dyskinesia. In Study 1, patients treated with Gocovri demonstrated statistically significant and clinically relevant reductions in dyskinesia, with a 37 percent reduction in Unified Dyskinesia Rating Scale (UDysRS) total score vs. 12 percent for placebo at Week 12. In Study 2 Gocovri achieved a 46 percent reduction in UDysRS vs. 16 percent for placebo. Additionally, key secondary data from Parkinson’s disease patient reported diaries in Study 1 and Study 2 respectively, showed that Gocovri-treated patients experienced a 3.6 and 4.0 hour increase in functional time daily (defined as ON time without troublesome dyskinesia) vs. a 0.8 and 2.1 hour increase for placebo-treated patients at Week 12. The increases in functional time were achieved by decreases in both ON time with troublesome dyskinesia and OFF time. The placebo-adjusted reduction in OFF time in both studies was approximately 1 hour per day.

Indication 2 - adjunctive treatment in patients with Parkinson’s disease experiencing OFF episodes

approved February 2021

Clinical Trial Results

Data from two pivotal, placebo-controlled Phase 3 clinical studies showed that treatment with Gocovri significantly reduced both OFF time and dyskinesia. This resulted in a clinically meaningful increase in good ON time in patients taking a levodopa-based medication for Parkinson’s disease. Additionally, GOCOVRI demonstrated sustained efficacy for at least two years in the Phase 3, open-label EASE LID-2 study.