Adamas: FDA Approves Gocovri for Dyskinesia

Friday, August 25, 2017 | FDA Approval/Clearance


FDA has approved Adamas Pharmaceuticals, Inc.’s 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 274mg amantadine (equivalent to 340mg amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day when dyskinesia occurs. Gocovri's positive benefit/safety profile was established in two Phase 3 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. These results were confirmed in Study 2 in which 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. The most commonly observed adverse reactions ( > 10 percent and greater than placebo) with Gocovri were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension. For additional Important Safety Information, see below.

"Today's approval is a tremendous milestone for Adamas and for the Parkinson's disease community," said Gregory T. Went, Ph.D., Founder, Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc., in a statement. “Gocovri has the potential to help people with Parkinson's disease suffering from dyskinesia by finally providing physicians with an effective tool to address this long-standing unmet medical need. We thank the physicians, clinical staff, patients and their families who participated in the clinical trials for making this advancement possible for the community."

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.

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