Sunovion refiles NDA for apomorphine sublingual film

Japan’s Sumitomo Dainippon Pharma (TYO: 4506) US subsidiary Sunovion Pharmaceuticals has resubmitted a new Drug Application (NDA) to the US Food and Drug Administration for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD).

This submission included information about intended packaging as well as additional analyses of clinical data. The move comes after Sunovion receiving a Complete Response Letter from the US regulator in January this year, calling for additional data and analyses, but not for further trials.

Apomorphine sublingual film is being developed as a fast-acting medicine for the on-demand treatment of all types of motor OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF. OFF episodes can cause severe disruption for someone living with PD, often causing a major disturbance in a person’s ability to maintain everyday activities. OFF episodes may worsen in frequency and severity over the course of the illness.1 While OFF episodes are experienced by 40% to 60% of people with PD, there are limited on-demand treatment options available for motor OFF episodes.