Sunovion Pharmaceuticals Inc. (Sunovion), a global biopharmaceutical company, has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) on March 29, 2018, for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease (PD).
Apomorphine sublingual film is being developed as a fast-acting medicine for the on-demand treatment of 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 may worsen in frequency and severity over the course of the illness.
“OFF episodes, which may be characterized by symptoms such as tremor, stiffness or slow movement, may disrupt the ability to perform everyday activities and may be burdensome for patients, families and caregivers,” said Antony Loebel, M.D., executive vice president and chief medical officer at Sunovion, head of global clinical development for Sumitomo Dainippon Pharma Group. “We are pleased to have submitted the NDA for apomorphine sublingual film for the treatment of OFF episodes and look forward to working with the FDA during the review period.”
Despite the significant impact of OFF episodes, which are experienced by 40 to 60 percent of people with PD, there are limited on-demand treatment options available for motor OFF episodes.
Sunovion’s NDA submission is supported by a pivotal, phase 3 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.
Apomorphine sublingual film (APL-130277), a novel formulation of apomorphine, a dopamine agonist, is being developed as a fast-acting sublingual film for the on-demand management of OFF episodes associated with Parkinson’s disease (PD). Apomorphine is currently the only molecule approved for the acute, intermittent treatment of hypomobility, “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) associated with advanced PD and is approved in the United States as a subcutaneous injection. Apomorphine sublingual film is designed to offer a potential solution that may be used to treat motor OFF episodes associated with PD up to five times throughout the day, which may help people with PD rapidly convert from the OFF to the ON state. Apomorphine sublingual film has not been approved by the US Food and Drug Administration (FDA). In October 2016, Sunovion acquired Cynapsus Therapeutics Inc. (Canadian Specialty Central Nervous System Biotechnology Company), along with its product candidate APL-130277.
CTH-300 (NCT02469090) was a pivotal, 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 people with levodopa-responsive Parkinson’s disease (PD) 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 prospectively specified 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.3 Study results will be presented at a future scientific congress and will be posted on ClinicalTrials.gov.
Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions.