Sunovion Pharmaceuticals submitted a new drug application to the FDA this week for its apomorphine sublingual film designed to treat motor fluctuations experienced by people with Parkinson’s disease.
The Marlborough, Mass.-based company is testing the 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.
“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,” Dr. Antony Loebel, EVP & CMO, said in prepared remarks.
Sunovion reported that the therapy performed well compared to a placebo in a pivotal Phase III trial and that the drug’s effect lasted for 90 minutes following initial administration. The film, which has fast-track status with the FDA, was also generally well tolerated by patients in the trial, according to the company.