Phase III EASE LID 2 study of Gocovri shows drug well tolerated in Parkinson's disease.- Adamas Pharma.

Adamas Pharmaceuticals announced the presentation of final results 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 U.S. Food and Drug Administration (FDA) for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Overall, final results from the two-year, open-label study demonstrated that Gocovri was generally well tolerated.

The data also showed the treatment effect of Gocovri 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 (N=78) or amantadine immediate release (IR) (N=32) and those with uncontrollable dyskinesia after deep brain stimulation (N=61) treatment, and was achieved without compromising the underlying control of Parkinson�s disease symptoms, as assessed by MDS-UPDRS, Parts I-III, which measures the non-motor and motor signs of Parkinson�s disease. These data were presented in two posters at the 22nd International Congress of Parkinson�s Disease and Movement Disorders (MDS) in Hong Kong, China.

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.