Adamas Announces Final Results from the Two-Year Phase 3 Open-Label Study of GOCOVRI

Adamas Pharmaceuticals (Nasdaq:ADMS) today announced positive data from EASE LID 2, the company’s two-year Phase 3 open-label study of GOCOVRI™ (amantadine) extended release capsules, the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

As quoted in the press release:

“The completed Phase 3 open-label study further expands our understanding of the benefit/risk profile of GOCOVRI,” said Rajiv Patni, M.D., Chief Medical Officer of Adamas Pharmaceuticals, Inc. “The large reduction in dyskinesia and OFF, as assessed by the Part IV score of the MDS-UPDRS, was observed by the first visit at Week 8 and was sustained for two years. This durability is noteworthy given the known progression of motor complications. Nine percent of patients discontinued GOCOVRI due to an adverse drug reaction over this prolonged treatment period and the safety as well as tolerability remained consistent with that obtained from the 64-week data cut from December 2016. Lastly, by two years, 30 percent of patients increased their levodopa dose by an average of approximately 300 mg, suggesting that GOCOVRI treatment may allow neurologists to further optimize their patient’s levodopa dose despite the occurrence of dyskinesia.”

Click here to read the full press release.