Parkinson's Disease Drug Meets Phase 3 Endpoints

Sunovian Pharmaceuticals announced its experimental treatment for patients with Parkinson’s disease (PD) who experience motor fluctuations called OFF episodes met the primary and secondary key endpoints of clinical trial, according to a company press release.

Sunovian plans to submit a new drug application for apomorphine sublingual film. It was previously granted Fast Track Designation by the FDA.

The findings from the phase 3 clinical trial of the drug, CTH 300, will be presented at an upcoming medical congress.

PD affects more than 1 million people in the United States, with symptoms that include tremors, rigidity, impaired movement, cognitive impairment, and mood disorders. OFF episodes occur when motor fluctuations disrupt the everyday lives of patients with PD, according to the release.

OFF-related motor fluctuations can typically be controlled by medication, but they can reappear in the morning and as the day goes on. According to Sunovian, approximately 40% to 60% of patients with PD are affected by OFF episodes, which can inhibit their movement and performance throughout the day.

These episodes of motor fluctuations can be difficult to live with, both emotionally and practically, according to the clinical trial.

“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, MD, 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.”

Apomorphine sublingual film has been found to be an effective and well-tolerated treatment for OFF episodes, according to Sunovion. It can be taken up to 5 times per day as needed during an OFF episode for patients to rapidly regain control over their motor functions, according to the release.

The researchers found that the treatment was generally well-tolerated, with the most common adverse events reported as nausea, somnolence, dizziness, yawning, and headaches.

The double blind clinical trial included 109 adults who were treated with apomorphine sublingual film and placebo. According to Sunovian, those treated with the drug experienced significant improvement in their OFF episodes.

There was a significant increase in the ON response rate among patients administered apomorphine sublingual film, according to the release.

These findings suggest that apomorphine sublingual film may be safer, easier to use, and more cost effective than the apomorphine injections that are currently used to treat OFF episodes.

“If an alternative method to deliver the medicine were approved, such as apomorphine sublingual film, it would be an important new option for health care providers and people with Parkinson’s disease,” said Stewart Factor, DO, 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.”