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.