FDA Gives "Female Viagra" Another Shot; Critics Shout Bias

Sprout Pharmaceuticals announced last week that their Formal Dispute Resolution, filed in December 2013, resulted in clear guidance from the FDA on the path to resubmit the New Drug Application for flibanserin, a once-daily treatment for Hypoactive Sexual Desire Disorder in premenopausal women.

Sprout appears optimistic: “We are encouraged by the FDA’s response and view it as a significant step toward the approval of flibanserin,” said Cindy Whitehead, president and chief operating officer of Sprout Pharmaceuticals.

But the same can't be said for women's groups and consumer media, who are pointing out the disparity in the number of FDA drugs approved for male sexual dysfunction (24) versus female (0). Critics say the FDA may be reflecting a societal bias when it comes to dealing with women's sexual disfunction versus that of men.

“It looks to me like there are more hurdles being put in front of this drug than there have been on drugs addressing male dysfunction,” said Terry O’Neill, president of NOW.

The FDA has requested that Sprout complete two additional Phase I drug interaction studies and a Phase I driving simulator study. Each study is expected to include approximately 25-50 healthy volunteers.

Sprout estimates it can complete the studies and resubmit flibanserin for approval by the third quarter.

Some history on flibanserin's path to approval: In June 2010, an FDA advisory committee declined to recommend approval for flibanserin, a compound that Boehringer Ingelheim was originally pursuing. The FDA told Boehringer that it would need more data to support flibanserin’s efficacy and safety profile. Boehringer soon chose to discontinue development of flibanserin, which was then aquired by Sprout Pharmaceuticals in 2012.

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