Phase III trial of APL 130277 in Parkinsons disease met primary endpoint.

Sunovion Pharmaceuticals announced topline results from its pivotal Phase III randomized, double-blind, placebo-controlled clinical trial, CTH-300, that evaluated APL 130277 (apomorphine sublingual film) in patients with Parkinson’s disease (PD) who experience motor fluctuations (OFF episodes). Study CTH-300 met its primary and key secondary endpoints, and the medicine was also generally well-tolerated by study participants. The Phase III study met its primary endpoint, with initial results from 109 adults with PD showing that individuals with OFF episodes who received apomorphine sublingual film demonstrated a statistically significant mean reduction in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score from pre-dose to 30 minutes after dosing at Week 12 compared with the placebo group. Effects persisting until the last observed time point at 90 minutes.

The difference in MDS-UPDRS Part III score change from baseline 30 minutes after dosing between apomorphine sublingual film and placebo was 7.6 (p=0.0002). The MDS-UPDRS Part III scale is used to assess the motor signs of PD.3 The study also met its key secondary endpoint, showing that a statistically significant greater percentage of people treated with apomorphine sublingual film (35 percent predicted response rate) had a patient-rated full ON response within 30 minutes after dosing at Week 12 compared with the placebo group (16 percent predicted response rate).