Sunovion seeking FDA approval for Parkinson's drug
Photo | Grant Welker
Sunovion's Marlborough headquarters
Sunovion Pharmaceuticals of Marlborough is seeking for the second time U.S. Food and Drug Administration approval for a new drug aimed at helping Parkinson's disease patients.
The pharmaceutical company's new submission, which it disclosed Friday, provides the FDA with additional analyses of clinical data and of Sunovion's planned packaging for the drug.
The drug, called an apomorphine sublingual film, treats motor fluctuations afflicting people with Parkinson's, a progressive neurodegenerative disease affecting an estimated 1 million people in the United States and 10 million worldwide, according to the Parkinson's Foundation. The drug, a dopamine agonist, can be used up to five times a day to treat symptoms.
Limited on-demand treatment options exist today for Parkinson's motor symptoms, Sunovion said.
The drug was first developed by Cynapsus Therapeutics Inc., a Canadian firm Sunovion acquired for $624 million in 2016.
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