FDA to Review Sublingual Tx for Motor Fluctuations in Parkinson's Disease
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.