The U.S. Food and Drug Administration has provided a Refusal to File (RTF) letter regarding Accorda Therapeutics' New Drug Application (NDA) for Inbrija, an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
The FDA delivered the RTF after determining that the NDA was not sufficiently complete.
According to the FDA, the problems occurred with the date given for when the company’s manufacturing site would be ready for inspection and with the submission of the master drug production record. Accorda will seek guidance and clarification so it can provide the appropriate information.
“We will work with the FDA as quickly as possible to address the open issues and to clarify the path to successfully re-file our application,” Ron Cohen, Acorda's president and CEO, said in a statement. “We remain confident in Inbrija's data package and its promise as an important new therapy for people with Parkinson's disease. We see tremendous long-term value in its solid clinical profile, significant commercial opportunity and strong IP, and we remain focused on working to bring patients this important new therapy.”