Acorda Therapeutics said that it has resubmitted an NDA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson’s disease patients. The company originally submitted the 505(b)(2) application in June 2017, and the FDA issued a refuse to file letter in response in August 2017.
According to Acorda, the resubmitted application addresses two issues cited by the FDA in the RTF letter, which the company previously said were concerns about the availability of the manufacturing facility for inspection and about the drug master production record.
The application is supported by Phase 3 trial data for Inbrija, formerly known as CVT-301, showing that the DPI significantly improved motor function in Parkinson’s disease patients who experience OFF periods.
Read the Acorda Therapeutics press release.
