Sunovion Pharmaceuticals said yesterday that the FDA rejected its New Drug Application for its apomorphine sublingual film designed to treat motor fluctuations in people living with Parkinson’s disease.
The Marlborough, Mass.-based 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.
Sunovion said that the FDA “determined it was unable to approve the apomorphine sublingual film NDA in its present form,” according to a press release.
The company said that the federal watchdog requested additional information and analysis, but that no new clinical studies would be required for approval.
“OFF episodes are a common and challenging part of Parkinson’s disease with few existing treatment options. Sunovion remains committed to working with the FDA to address its requests so that we can bring apomorphine sublingual film to patients as expeditiously as possible,” Sunovion chief medical officer Dr. Antony Loebel said in a press release.
The FDA accepted the NDA from Sunovion last June, and said it would make a decision by January 29.