Acorda Therapeutics has submitted a 505(b)(2) new drug application for Inbrija (CVT-301) levodopa for the treatment of symptoms during OFF periods in Parkinson’s disease patients, the company said. According to the company, the FDA is expected to inform the company whether or not the application has been accepted by the end of September.
In May 2017, Acorda announced that it was preparing the NDA based on data from the SPAN-PD Phase 3 study. Two long-term safety studies in Parkinson’s patients are underway.
In the May announcement, Acorda said that it planned to submit an MAA in Europe for CVT-301 by the end of the year, and the company says that it is still on track for that submission.
Acorda Chief Medical Officer Burkhard Blank said, “There is a tremendous need for new treatment options for OFF periods, which are regularly cited by people with Parkinson’s as one of the most problematic aspects of their disease. On behalf of the Parkinson’s community, we are pleased to submit this promising therapy for FDA review.”
CVT-301 was initially developed by Civitas Therapeutics which was acquired by Acorda in 2014.
Read the Acorda press release.
