Final results from the Phase 3 EASE LID 2 study of Gocovri (amantadine extended-release capsules; Adamas) showed that the treatment effect on motor complications (dyskinesia and OFF time) was maintained for up to 2 years in Parkinson disease (PD) patients with dyskinesia receiving levodopa-based therapy.
The open-label safety study included patients from 3 Gocovri dyskinesia efficacy trials (N=223) and evaluated the long-term safety and tolerability of the treatment; secondary endpoints included 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 progression of PD as assessed by the MDS-UPDRS, Parts I, II, and III.
Results showed that Gocovri was generally well-tolerated, with a safety profile similar to that seen in previous clinical trials. Treatment with Gocovri provided a comparable 35% reduction in dyskinesia and OFF time from baseline by Week 8 that was maintained for up to 100 weeks across all subgroups (ie, those switched from placebo or amantadine immediate-release and those with uncontrollable dyskinesia after deep brain stimulation); this effect was achieved without impacting the clinical progression of PD in these patients. In addition, over 84% of patients treated with Gocovri maintained or increased their levodopa dosage for up to 100 weeks.
“These open label study results demonstrate how the Gocovri Phase 3 controlled clinical data can translate into real-world benefits,” said Caroline Tanner, MD, PhD, Professor at University of California San Francisco. “There is now up to 2 years of clinical evidence that further supports the overall safety profile and efficacy of Gocovri is consistent with previously reported data from the 2 pivotal Phase 3 studies.”
Gocovri is FDA-approved for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is supplied as an extended-release capsule in 2 dosage strengths: 68.5mg and 137mg. The treatment is taken at bedtime and delivers high levels of amantadine upon waking and throughout the day.
For more information visit Gocovri.com.
This article originally appeared on MPR