Sunovion Pharma announced that the U.S. FDA issued a Complete Response Letter for the New Drug Application for the drugmaker's apomorphine sublingual film to treat OFF episodes experienced by people living with Parkinson’s disease.
Upon review of the application, the FDA determined that it was unable to approve the Massachusetts-based drugmaker's NDA without additional information and analyses, but did not ask for new clinical trials.
The new drug was expected to compete against Acorda Therapeutics' drug, Inbrija, which won FDA approval in December.
Sunovion says it remains committed to working with the agency to address its requests.
Read the press release