Sunovion Pharmaceuticals Inc. (Sunovion) today announced topline results from its pivotal Phase 3, randomized, double-blind, placebo-controlled clinical trial, CTH-300, that evaluated apomorphine sublingual film (APL-130277) 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.
Apomorphine sublingual film is being developed to treat 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 are characterized, in part, by tremor, stiffness or slow movement. These episodes may disrupt a person’s ability to perform everyday activities and are burdensome for patients, family and caregivers. OFF episodes are experienced by as many as 40 to 60 percent of people with PD and may worsen in frequency and severity over the course of the illness.1
"For people with Parkinson’s disease and their families, OFF episodes can have a significant emotional and practical impact, and there are currently few treatment options for these events," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. "Based on these topline results, we believe that apomorphine sublingual film has the potential to be a well-tolerated, reliable, convenient and fast-acting therapeutic option for people living with Parkinson’s disease who struggle with OFF episodes."
The Phase 3 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, with effects persisting until the last observed time point at 90 minutes.2 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).2
"Apomorphine is a potent antiparkinsonian medication that is underutilized in Parkinson’s disease patients with troublesome OFF episodes. Apomorphine is currently only available as an injection. If an alternative method to deliver the medicine were approved, such as apomorphine sublingual film, it would be an important new option for healthcare providers and people with Parkinson’s disease," said Stewart Factor, D.O., Professor of Neurology, Director of the Movement Disorders Program and Vance Lanier Chair of Neurology at Emory University School of Medicine, and the primary investigator on the CTH-300 study. "The study reported here demonstrated that sublingual apomorphine rapidly and safely converted people with Parkinson’s disease from the OFF to the ON state."
Apomorphine sublingual film was generally well-tolerated in the study population. The most commonly reported treatment-emergent adverse events during both the titration and maintenance treatment phases were nausea (27.0 percent), somnolence (14.9 percent), dizziness (14.2 percent), yawning (12.8 percent) and headache (9.2 percent).
Full results of ...
(All Rights Reserved)