Sunovion Pharma files NDA at FDA for apomorphine sublingual film to treat OFF episodes for Parkinson's disease.

Sunovion Pharmaceuticals Inc.has announced that it has submitted a new drug application (NDA) to the FDA on March 29, 2018, for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson's disease (PD). 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 occur when PD symptoms, otherwise controlled by medications, re-emerge. OFF episodes can happen at any point during the day, often occurring in the morning after awakening and periodically throughout the day. OFF episodes may worsen in frequency and severity over the course of the illness. Despite the significant impact of OFF episodes, which are experienced by 40 to 60 percent of people with PD, there are limited on-demand treatment options available for motor OFF episodes.

Sunovion's NDA submission is supported by a pivotal, Phase III study, CTH-300, which met its primary and key secondary endpoint. In the study, apomorphine sublingual film demonstrated superior efficacy versus placebo for the on-demand treatment of OFF episodes associated with PD, with the effect persisting until the last observed time point at 90 minutes. The study also showed that apomorphine sublingual film was generally well-tolerated by study participants. The FDA has granted Fast Track Designation for apomorphine sublingual film.

Comment: APL 130277 is an easy-to-administer, fast-acting reformulation of apomorphine (a sublingual (oral) thin film strip) which is the only approved drug in the United States, Europe, Japan and other countries, to rescue patients from "off" episodes experienced with Parkinson's disease.