Adamas announced positive long-term data from the Phase 3 EASE LID 2 trial which evaluated Gocovri (amantadine extended-release) in Parkinson’s disease patients with dyskinesia on levodopa-based therapy.
The 2-year study (N=223) enrolled patients from the 3 placebo-controlled efficacy trials: EASED, EASE LID, and EASE LID 3. The primary purpose was to determine the long-term safety and tolerability of Gocovri administered once-daily at bedtime; secondary objectives included the durability of Gocovri on motor complications as assessed by the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Part IV, and clinical disease progression as assessed by MDS-UPDRS Parts I, II, and III.
The new data showed Gocovri was well tolerated and the treatment effect on motor complications (OFF episodes and dyskinesia), as measured by the MDS-UPDRS Part IV, was maintained for up to 2 years. This benefit was observed in all patient subgroups, including patients who switched to Gocovri from placebo or amantadine immediate-release (IR), and patients with uncontrollable dyskinesia after deep brain stimulation (DBS) treatment. In addition, by 2 years, 30% of patients had increased their levodopa dose by ~300mg, indicating that treatment with Gocovri may allow for further levodopa optimization despite the occurrence of dyskinesia.
“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,” stated Rajiv Patni, MD, CMO of Adamas Pharmaceuticals.
Findings from this analysis further validate previous data from the 64-week interim analysis. At Week 100, there was a change from baseline in the MDS-UPDRS, Part IV, score of -2.4 units in patients treated with placebo, -3.5 units in patients treated with amantadine IR, and -3.6 units in patients treated with deep brain stimulation. Among patients previously treated with Gocovri, the change from baseline was -0.4 units.
Over the 2-year study period, 9% of patients discontinued Gocovri due to adverse drug reactions. The most commonly reported adverse drug reactions were falls, hallucination, peripheral edema, constipation, urinary tract infection, dizziness, nausea, insomnia, livedo reticularis, dry mouth, depression, anxiety, and abnormal dreams.
Gocovri, a dopamine agonist, is available as 68.5mg and 137mg extended-release capsules in 60-count bottles.
For more information call (510) 450-3500 or visit Gocovri.com.