Sunovion Apomorphine Sublingual Film Meets Primary and Secondary Endpoints in Parkinson's Disease Patients.
M2 PHARMA-February 2, 2018-Sunovion Apomorphine Sublingual Film Meets Primary and Secondary Endpoints in Parkinson's Disease Patients
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- Marlborough, Massachusetts-based global biopharmaceutical company Sunovion Pharmaceuticals Inc. has released topline results from its Phase 3 clinical trial, CTH-300, that evaluated apomorphine sublingual film (APL-130277) in patients with Parkinson's disease who experience motor fluctuations (OFF episodes), the company said.
Apomorphine sublingual film is being developed to treat all types of motor OFF episodes, characterized, in part, by tremor, stiffness or slow movement, that may disrupt a person's ability to perform everyday activities and are burdensome for patients, family and caregivers.
CTH-300 was a 12-week, randomized, double-blind, placebo controlled, parallel group, Phase 3 study examining the efficacy, safety and tolerability of apomorphine sublingual film (APL-130277) in 109 adults with levodopa-responsive Parkinson's disease complicated by OFF episodes.
The Phase 3 study met its primary endpoint, 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 study also met its key secondary endpoint, showing that a statistically significant greater percentage of people treated with apomorphine sublingual film had a patient-rated full ON response within 30 minutes after dosing at week 12 compared with the placebo group.
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, somnolence, dizziness, yawning, and headache.
Sunovion, an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is a global biopharmaceutical company focused on research and development of treatments for psychiatric, neurological, and respiratory conditions.
Sunovion Pharmaceuticals Europe Ltd., based in London, England, and Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
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|Date:||Feb 2, 2018|
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