APL 130277 has Complete Response from FDA as a treatment for Parkinson's disease-Sunovion Pharma
Sunovion Pharmaceuticals Inc. announced that the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) 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 (PD).
Upon review of the application, the FDA determined that it was unable to approve the apomorphine sublingual film NDA in its present form. The Agency requested additional information and analyses, but no new clinical studies are required..
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