Makers of Drug for Female Sexual Dysfunction Appeal FDA Rejection - East Idaho News

Makers of Drug for Female Sexual Dysfunction Appeal FDA Rejection

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GETTY 121113 WomanPills?  SQUARESPACE CACHEVERSION=1386826286164Photodisc/Thinkstock(WASHINGTON) — Researchers hoping to come up with a new pill to boost a woman’s libido are headed back to the drawing board.  

Sprout Pharmaceuticals had been working on a drug some have called the female Viagra that would act on brain chemicals linked to mood and appetite to stimulate a woman’s sex drive. But the study that had been in development for 15 years has hit a roadblock, with the FDA questioning whether flibanserin’s risk of side effects like nausea, dizziness and tiredness were too high.

Sprout describes flibanserin as “an investigational, once-only treatment for Hypoactive Sexual Desire Disorder, or HSDD, in premenopausal women.” The company says HSDD is the most commonly reported form of female sexual dysfunction.

The FDA has denied approval of the drug. Sprout is appealing, and on Wednesday Cindy Whitehead, president and COO of Sprout, released the following statement:

“Sprout strongly believes that it has satisfied the statutory requirements for approval of flibanserin. In clinical trials, flibanserin has outperformed placebo with statistical significance and, importantly, women treated with flibanserin perceived their improvement to be clinically meaningful. What the Division characterizes as a modest effect in their risk/benefit evaluation, we see as meaningful effect on the hallmark characteristics of the condition. It is the basis of our dispute. It is true that flibanserin does not cause hypersexuality, but by that definition, modest would be what we’re aiming for. Further, in the risk/benefit evaluation, we believe that the safety profile of flibanserin is similar to that of other approved drugs where effect was characterized as modest by the agency and can be managed through a combination of labeling and responsible product launch, including post-market assessments and communications. If approved, flibanserin could meet an important unmet medical need for women.”  

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