NDA Submitted for Sublingual Film to Treat OFF Episodes in Parkinson's Disease
Sunovion announced the submission of its New Drug Application (NDA) for apomorphine sublingual (SL) film (APL-130277) for the treatment of motor fluctuations (OFF episodes) associated with Parkinson's disease.
Apomorphine SL film, a dopamine agonist, is intended for on-demand treatment of all types of motor OFF episodes, including morning OFF, unpredictable OFF and end-of-dose wearing OFF. The novel SL formulation may potentially be used to treat OFF episodes up to 5 times throughout the day. Apomorphine is currently available as a subcutaneous injection for use in advanced Parkinson's disease.
The NDA submission included data from Phase 3, 12-week, randomized, double-blind, placebo-controlled, parallel-group study (CTH-300) that enrolled patients with levodopa-responsive Parkinson's disease complicated by OFF episodes. The primary endpoint was a mean change from pre-dose in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination at 30 minutes after dosing at the 12-week visit of the Maintenance Treatment Phase. The key secondary endpoint was the percentage of people with a patient-rated full ON response within 30 minutes at the 12-week visit of the Maintenance Treatment Phase.
The study met its primary and key secondary endpoint as treatment with apomorphine SL film led to superior efficacy compared with placebo for the on-demand treatment of OFF episodes associated with Parkinson's disease. The clinical effect was observed until the last time point at 90 minutes. The study drug was also generally well-tolerated by the patients.
Apomorphine SL film has been granted Fast Track Designation by the FDA.
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