Raleigh-based Sprout Pharmaceuticals is trying again to help premenopausal women get in the mood.
The company confirmed Wednesday that it submitted the drug flibanserin for Food and Drug Administration review earlier this year. Flibanserin, originally developed as an antidepressant, is now being evaluated as a treatment for Hypo-Active Sexual Desire Disorder in premenopausal women. This is second time that the drug has been submitted to the FDA as a treatment for HSDD.
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 recent medical study published in the Journal of Sexual Medicine.
The study, published last month, detailed the results of a placebo-controlled clinical trial. For 24 weeks, nearly 1,100 middle-aged premenopausal women with HSDD were treated with either flibanserin or a placebo once daily at bedtime. The researchers concluded that the women treated with flibanserin experienced a significantly higher number of sexually satisfying experiences during the time of study.
This additional data, which is a key part of Sprouts resubmission of the flibanserin new drug application, is responsive to feedback received from FDA previously, Sprouts chief operating officer Cindy Whitehead said in a statement. With this study, and other information included in our resubmission, Sprout believes that it has addressed the concerns raised by the FDA during its previous review.
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, sometimes referred to as pink Viagra, for evaluation as a treatment for HSDD. The FDA voted against the drugs approval in 2010 after concluding that flibanserin did not treat HSDD significantly better than a placebo, and that the drugs benefits did not outweigh its adverse effects.
Women taking flibanserin have reported feeling drowsy, nauseous and dizzy, and the study published last month reported that nearly 10 percent of women who experienced flibanserins adverse effects stopped taking it. About 4 percent of women given the placebo stopped taking it for the same reason.
The FDA is expected to respond to the new drug application this year.