EASE LID 2 phase III trial of Gocovri shows benefits maintained to 2 years in Parkinson's dyskinesia.- Adamas Pharmaceuticals.

Adamas Pharmaceuticals announced positive data from EASE LID 2, the company�s two-year Phase III open-label study of Gocovri (amantadine) 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 (dyskinesia and OFF), as measured by the Movement Disorder Society-Unified Parkinson�s Disease Rating Scale (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 (IR), as well as a subgroup of patients with uncontrollable dyskinesia after deep brain stimulation (DBS) treatment.

This final analysis extends and confirms the previously reported results from the 64-week interim analysis published in the Journal of Parkinson�s Disease in 2017. At Week 100, the change from baseline in the MDS-UPDRS, Part IV, score was a decrease of -2.4, -3.5, -3.6 units, in patients previously treated with placebo, amantadine IR and DBS, respectively. In contrast, the change from baseline in the previously treated Gocovri patients was 0.4 units, demonstrating little change in patients who were already receiving Gocovri prior to entry in this open-label study.

The safety data are consistent with the previously reported safety profile of Gocovri , which includes precautions and warnings related to suicidality, hallucinations, dizziness and orthostatic hypotension. During the two-year study, nine percent of patients discontinued due to adverse drug reactions (ADRs). Most adverse drug reactions were of mild to moderate intensity. These data are planned to be presented at the 22nd International Congress of Parkinson�s Disease and Movement Disorders.

Comment: Levodopa is a standard treatment for Parkinsons disease but comes with severe side effects (levodopa induced dyskinesia) that worsen with continued exposure to the drug that is estimated to affect some 15% of Parkinsons patients. Gocovri is a high dose 274 mg amantadine (equivalent to 340 mg amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day when dyskinesia occurs.