30 January 2019 - Sunovion Pharmaceuticals announced today that the U.S. FDA issued a complete response letter for the new drug application for apomorphine sublingual film (APL-130277) to treat OFF episodes (the re-emergence or worsening of Parkinson’s symptoms otherwise controlled by medications) experienced by people living with Parkinson’s disease.

Upon review of the application, the FDA determined that it was unable to approve the apomorphine sublingual film application in its present form. The Agency requested additional information and analyses, but no new clinical studies are required.

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