Acorda Therapeutics Inc. reported positive data from its phase 3 trial of CVT-301 in people with Parkinson's experiencing OFF periods.
OFF periods refer to the re-emergence of Parkinson's symptoms.
The study met its primary endpoint, with the drug showing statistically significant improvement in motor function compared to placebo as measured by mean change in the Unified Parkinson's Disease Rating Scale – Part III, in patients experiencing OFF periods, at 30 minutes post-dose at week 12.
Multiple secondary endpoints, including achievement of an ON state with maintenance through 60 minutes and Patient Global Impression of Change, were supportive of the primary endpoint result.
Acorda plans to file a new drug application with the U.S. Food and Drug Administration by the end of the second quarter of 2017, and a marketing authorization application with the European Medicines Agency by the end of 2017.