Gearing up for a springtime FDA submission, Sunovion Pharmaceuticals reported today that its apomorphine sublingual film succeeded in a pivotal Phase III trial in patients with Parkinson’s disease who experience motor fluctuations.
Without revealing the study’s full results, the Marlborough, Mass.-based company said that the trial met its primary and key secondary endpoints and that the drug was generally well-tolerated by patients.
Sunovion is testing the sublingual film as a therapy for Parkinson’s patients experiencing “off” episodes, when symptoms that are otherwise controlled by medications resurface. As many as 60% of Parkinson’s patients have these kinds of episodes, according to the company.
“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,” Dr. Antony Loebel, EVP & chief medical officer at Sunovion, said in prepared remarks. “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 109-patient study found that people who used Sunovion’s sublingual film had statistically significant improved motor function after 12 weeks compared to those in the placebo group. The trial also showed that a statistically significant greater protion of people treated with the drug had an “on” response within 30 minutes after dosing at 12 weeks compared to the placebo group.
“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,” primary investigator Dr. Stewart Factor added. “The study reported here demonstrated that sublingual apomorphine rapidly and safely converted people with Parkinson’s disease from the OFF to the ON state.”
The most common treatment-related side effects reported by patients were nausea, somnolence, dizziness, yawning and headache.
Sunovion plans to submit a new drug application to the FDA for its sublingual film, which was given fast-track status from the regulatory agency, later this spring.
In August last year, Acorda was dealt a setback when the FDA said it wouldn’t review the regulatory application for Inbrija. The company resubmitted its NDA to the agency in December and will soon know whether or not it was accepted for review.
ACOR shares were down -2% in mid-morning activity today, trading at $26.95 apiece.