Sunovion Pharmaceuticals said today that the FDA accepted its new drug application for a sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease.
The U.S. regulatory agency is slated to make a decision regarding Sunovion’s application by January 29.
The company’s product is a fast-acting therapy based on a novel formulation of an FDA-approved drug, apomorphine. Sunovion is assessing its apomorphine sublingual film as a therapy for Parkinson’s patients experiencing “off” episodes, in which symptoms that are usually controlled by medications resurface.
“Through our ongoing work with people living with Parkinson’s disease, we know the community is eager for more treatment options that may help alleviate ‘Off’ episodes, which are often disruptive to their daily lives,” Todd Sherer, CEO of The Michael J. Fox Foundation for Parkinson’s Research, said in prepared remarks.
“We are encouraged that the FDA has accepted our NDA for apomorphine sublingual film,” Dr. Antony Loebel, CMO and EVP at Sunovion, added. “There are currently few treatment options available to Parkinson’s disease patients for the as-needed treatment of ‘Off’ episodes. We look forward to working with the FDA during the review period so that we can bring a much needed new treatment option to people living with Parkinson’s disease and ‘Off’ episodes.”