BRIEF — Sunovion's NDA accepted for motor fluctuations in Parkinson's

14 June 2018

Sunovion Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD).

While OFF episodes are experienced by 40 to 60% of people living with PD, there are limited on-demand treatment options available.

East Coast, USA-based Sunovion, which is a wholly-owned subsidiary of Japan’s Sumitomo Dainippon Pharma, has been told that the FDA will make a decision by January 29.