30 March 2018 - Submission is supported by Phase 3 clinical study data showing that the investigational medicine demonstrated superior efficacy versus placebo for the on-demand treatment of 'off' episodes associated with Parkinson’s disease.

Sunovion today announced that it has submitted a new drug application to the U.S. FDA on 29 March 2018, for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD).

Sunovion’s submission is supported by a pivotal, Phase 3 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.

Read Sunovion Pharmaceuticals press release