Sunovion accepted for Parkinson's drug submission
Photo | Grant Welker
Sunovion's Marlborough headquarters
Sunovion Pharmaceuticals has been approved by the U.S. Food and Drug Administration for a new drug application to quickly treat Parkinson's disease motor fluctuation episodes, the Marlborough company said Friday.
Sunovion submitted the application in November for the second time, providing the FDA with additional analyses of clinical data.
The drug, a dopamine agonist, is a film that dissolves under the tongue that can be used up to five times a day to treat motor fluctuations, known as OFF episodes, affecting people with Parkinson's, a progressive neurodegenerative disease. Limited on-demand treatment options exist today for Parkinson's motor symptoms, Sunovion said.
If approved, Sunovion said, the drug would be the first and on-demand treatment for OFF episodes that is administered sublingually, or under the tongue.
Sunovion said it expects FDA action on its review of the drug by May 21.
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