Sunovion seeking FDA approval for eating disorder medication
Photo | Grant Welker
Sunovion's Marlborough headquarters
Marlborough pharmaceutical firm Sunovion is applying for U.S. Food and Drug Administration approval for a new drug to treat binge eating disorder.
The drug, called dasotraline, would treat adults with moderate to severe cases of the eating disorder, which Sunovion said is estimated to affect 4.1 million Americans and occur at rates three times higher than anorexia and bulimia combined.
Sunovion said Tuesday that the FDA has accepted the company's new drug application for review.
Clinical data for the drug showed that once-daily medication significantly reduced the number of binge days for adults with moderate-to-severe binge eating disorder, and was shown to be generally well-tolerated by patients. The test took place during two 12-week, randomized, placebo-controlled studies.
Binge eating disorder involves frequently consuming unusually large amounts of food and feeling unable to stop eating. It is similar to bulimia, a condition when people also overeat but compensate by vomiting to avoid gaining weight.
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