Sunovion Submits NDA for Sublingual Parkinson's Treatment
Sunovion Pharmaceuticals, headquartered in Marlborough, Massachusetts, announced it submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for apomorphine sublingual film to treat OFF episodes in Parkinson’s disease (PD).
Apomorphine is a dopamine agonist, and apomorphine sublingual film is a novel formulation of the drug. Sublingual films are applied under the tongue, where the drug can be rapidly absorbed. Apomorphine is the only molecule currently approved for acute, intermittent treatment of hypomobility, or OFF episodes associated with advanced PD. At this point, apomorphine is only approved in the U.S. for subcutaneous injection.
Apomorphine film (CTH-300) was evaluated in a pivotal, 12-week, randomized, double-blind, placebo-controlled Phase III trial. The primary endpoint was a mean change 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 during the Maintenance Treatment Phase. The key secondary endpoint was the percentage of patients with a patient-rated full ON response within 30 minutes at the 12-week point. Both endpoints were met.
“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, Sunovion’s executive vice president and chief medical officer, head of Global Clinical Development for Sumitomo Dainippon Pharma Group, in a statement. “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.”
Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma.
The Phase III study results had been reported on January 29, 2018. It investigated 109 adults with PD. “Apomorphine is a potent antiparkinsonian medication that is underutilized in Parkinson’s disease patients with troublesome OFF episodes,” said Stewart Factor, professor of Neurology, director of the Movement Disorders Program and Vance Lanier Chair of Neurology at Emory University School of Medicine, and primary investigator of the study, in a statement. “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. The study reported here demonstrated that sublingual apomorphine rapidly and safely converted people with Parkinson’s disease from the OFF to the ON state.”
In the study, the product was generally well-tolerated. The most commonly reported side effects were nausea, somnolence, dizziness, yawning and headache.
The FDA has granted the product Fast Track Designation.
About four to six million people around the world have PD, including about one million in the U.S. The disease is a chronic, progressive neurodegenerative disorder with motor symptoms, including tremors, rigidity and impaired movement. Non-motor symptoms include cognitive impairment and mood disorders. It is the second most common neurodegenerative disease after Alzheimer’s disease. About 40 to 60 percent of PD patients have OFF episodes, which tend to get worse and more common over the course of the disease.