Acorda Submits New Drug Application to U.S. Food and Drug Administration for INBRIJA

Acorda Therapeutics, Inc. has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for INBRIJATM(CVT-301, levodopa inhalation powder). Acorda is developing INBRIJA as a treatment for symptoms of OFF periods in people with Parkinson's taking a carbidopa / levodopa regimen. OFF periods refer to the re-emergence of Parkinson's symptoms. The trade name for CVT-301, INBRIJA, has been conditionally accepted by the FDA.

The NDA was submitted as a 505(b)(2) application. Based on current guidelines, the Company anticipates the FDA to inform Acorda by the end of September if the submission has been deemed complete and permits a full review.

"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," said Burkhard Blank, M.D., Chief Medical Officer of Acorda. "On behalf of the Parkinson's community, we are pleased to submit this promising therapy for FDA review."

The NDA for INBRIJA includes data from a Phase 3 safety and efficacy study (SPAN-PD), as well as results from two ongoing long-term safety studies in people with Parkinson's. Findings from these studies support the filing of INBRIJA for use on an as needed basis to address symptoms of OFF periods. Data from the SPAN-PD trial were presented as a late-breaking poster at the International Congress of Parkinson's Disease and Movement Disorders (MDS) in June 2017.

The Company plans to file a Marketing Authorization Application (MAA) in Europe for CVT-301 by the end of 2017.