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.
The FDA has set a target Prescription Drug User Fee Act (PDUFA) date for January 29, 2019.
For more information call (800) 739-0565 or visit Sunovion.com.