Adamas Pharmaceuticals, Inc. (Nasdaq: ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the publication of an article entitled "Amantadine ER (Gocovri®) significantly increases ON time without any dyskinesia: Pooled analyses from pivotal studies in Parkinson’s disease" in the peer-reviewed journal Frontiers in Neurology. GOCOVRI® (amantadine) extended release capsules is the first and only medicine approved as a treatment both for dyskinesia in patients with Parkinson’s disease (PD) receiving levodopa-based therapy and as an adjunctive treatment to levodopa/carbidopa in patients with PD experiencing OFF episodes.
The publication examined data from two pivotal, placebo-controlled Phase 3 clinical studies evaluating a total of 196 patients. The results demonstrated that treatment with GOCOVRI more than doubled the daily time patients spent ON without any dyskinesia (whether troublesome or non-troublesome), from 3.9 hours a day at baseline to 8.4 hours at Week 12. Compared to placebo, those treated with GOCOVRI experienced an additional 2.9 hours ON time without dyskinesia, an increase driven by a reduction in both OFF time and dyskinesia. Typically, PD clinical trials for the treatment of motor complications differentiate dyskinesia into ‘troublesome’ and ‘non- troublesome’ categories. This analysis is unique in evaluating treatment impact by measuring the increase in ON time without any dyskinesia. GOCOVRI-related adverse events were consistent with the known safety profile of amantadine.
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