APL 130277 refiled with FDA for parkinsons disease.- Sunovion Pharma

Sunovion Pharmaceuticals announced that the FDA has accepted its New Drug Application (NDA) for APL 130277 (apomorphine sublingual film) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson�s disease (PD), which was resubmitted on November 21, 2019. The expected action date by the FDA under the Prescription Drug User Fee Act (PDUFA) is May 21, 2020.

Sunovion�s NDA submission in 2018 was 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.