FDA Rejects Female Viagra

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In this Friday, Sept. 27, 2013, photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters on Friday, Sept. 27, 2013.  Sprout Pharmaceuticals said Wednesday, Dec. 11, 2013, it has reached an impasse with the Food and Drug Administration over its drug, flibanserin. The daily pill is designed to increase libido in women by acting on brain chemicals linked to mood and appetite. (AP Photo/Allen G. Breed)
In this Friday, Sept. 27, 2013, photo, a tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters on Friday, Sept. 27, 2013. Sprout Pharmaceuticals said Wednesday, Dec. 11, 2013, it has reached an impasse with the Food and Drug Administration over its drug, flibanserin. The daily pill is designed to increase libido in women by acting on brain chemicals linked to mood and appetite. Photo: Allen Breed/AP/Corbis

Sprout Pharmaceuticals has reached an “impasse” with the FDA over its female libido drug, flibanserin, the AP reports, and will appeal the agency’s decision not to approve the drug. Flibanserin is the first — but not only — drug to approach low libido through brain chemistry, as opposed to blood flow. (It was first developed and rejected in 2011 by some of the same team working on Lorexys, a similar female libido drug currently in trials.) The FDA says flibanserin is not effective enough in trials (inspiring just 1.7 more "satisfying sexual experiences" per month than women taking placebos) to outweigh the side effects (nausea, dizziness, fatigue). Sprout executives counter that the number is statistically significant (when it’s between 1.7 and 0, I agree), especially considering there’s no alternative. “We've now got 24 drugs for men for either testosterone replacement or erectile dysfunction,” Cindy Whitehead, Sprout COO, told the AP. “Yet there are zero drugs for the most common form of sexual dysfunction in women.” In the meantime, regular old men’s Viagra may alleviate the symptoms of PMS.