Adamas Pharmaceuticals announces final results from GOCOVRI Phase 3 study
Adamas Pharmaceuticals announced positive data from EASE LID 2, the company's two-year Phase 3 open-label study of GOCOVRI extended release capsules, the first and only medicine approved by the FDA for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Overall, results demonstrated that GOCOVRI was generally well tolerated and the treatment effect on motor complications, as measured by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, or MDS-UPDRS, Part IV, was maintained for up to two years. This effect was seen in all subgroups, including those switched to GOCOVRI from placebo or amantadine immediate release, or IR, as well as a subgroup of patients with uncontrollable dyskinesia after deep brain stimulation, or DBS, treatment. These data are planned to be presented at the 22nd International Congress of Parkinson's Disease and Movement Disorders, or MDS, in Hong Kong, China. "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."