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.
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