Sunovion announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) seen in patients with Parkinson’s disease.

Apomorphine sublingual film is an investigational drug in development for fast-acting treatment of all types of motor OFF episodes (morning OFF, unpredictable OFF, and end-of-dose wearing OFF).  It is a new formulation of the dopamine agonist apomorphine, intended for rapid conversion from the OFF to the ON state; it has been studied to treat motor OFF episodes up to 5 times a day. 

Currently, apomorphine is the only drug approved for the acute, intermittent treatment of hypomobility, OFF episodes associated with advanced Parkinson’s disease, and is only available as a subcutaneous (SC) formulation. 

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The FDA has set a target Prescription Drug User Fee Act (PDUFA) date for January 29, 2019.

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