Sprout Pharma to file new drug application for ‘pink Viagra’ drug
02/11/2014 1:53 PM
02/11/2014 1:53 PM
Raleigh-based Sprout Pharmaceuticals announced Tuesday that it expects to resubmit a new drug application later this year for its drug to increase sexual desire in premenopausal women.
The announcement comes after Food and Drug Administration officials requested that Sprout complete three additional studies before moving forward. Sprout expects to file a new drug application by the third quarter.
The drug, flibanserin, is sometimes referred to as “pink Viagra.” It was originally developed as an antidepressant, but Sprout is seeking approval for it to be used as a once-daily treatment for Hypo-Active Sexual Desire Disorder in premenopausal women.
HSDD is defined as a recurrent deficiency of sexual thoughts or desire for sexual activity. The condition may affect about 10 percent of premenopausal women in the United States, according to a medical study published in the Journal of Sexual Medicine last year.
Flibanserin tempers the activity of certain neurotransmitters associated with causing HSDD. There are currently no drugs approved in the United States to treat HSDD.
Boehringer Ingelheim was the first pharmaceutical company to submit flibanserin for evaluation as a treatment for HSDD. The FDA voted against the drug's approval in 2010 after concluding that flibanserin did not treat HSDD significantly better than a placebo and that the drug's benefits did not outweigh its adverse effects.
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