Drug maker resubmits application for women's sex drive pill to FDA

"This year, I am optimistic that women and their partners affected by the life impact of HSDD will have their first potential medical solution," CEO Cindy Whitehead said.
By Brooks Hays   |   Feb. 17, 2015 at 10:33 AM
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WASHINGTON, Feb. 17 (UPI) -- The drug maker Sprout Pharmaceuticals has resubmitted a new drug application to the FDA for approval of a pill that claims to boost sex drive in premenopausal women. The drug, flibanserin, would be the first-ever approved by the FDA for female-specific treatment of hypoactive sexual desire disorder (HSDD).

The FDA has twice rejected the drug, but Sprout says its provided new information detailing the pill's safety and effectiveness. Politicians, pharmaceutical lobbyists and women's groups have all pressed the agency receive the newest application with an open mind.

With the overwhelming success of Viagra and its competitors, drug makers have been itching to break into the market of undersexed females.

"I believe that the agency's efforts to bring together panels of patients and clinical experts will prove to be a significant step in bringing about a solution for women with HSDD to market," Cindy Whitehead, CEO of Sprout Pharmaceuticals, said in a press release. "This year, I am optimistic that women and their partners affected by the life impact of HSDD will have their first potential medical solution."

While the causes of HSDD in both men and women remains an undecided topic among scientists, Sprout contends that the problem lies in neurotransmission. Imaging of prefrontal brain circuitry, the company and its researchers contend, show a marked difference in response to sexual stimuli among women diagnosed with HSDD and those without a diminished libido.

"The brain plays an important role in regulating a woman's sexual desire, and one of the root causes of persistent and recurrent low sexual desire, or HSDD, stems from an imbalance of neurotransmitters in the brain," explained Stephen Stahl, a psychiatry professor at the University of California San Diego, School of Medicine. "Flibanserin is believed to work by correcting this imbalance and providing the appropriate areas of the brain with a more suitable mix of brain chemicals to help restore sexual desire."

In Phase Three clinical testing, flibanserin consistently improved sexual desire in female test subjects. It also diminished the psychological distress over a diminished libido and double the number of satisfying sexual experiences enjoyed by study participants.

But it also cause sleepiness in 10 percent of testers, and there are concerns that it could interfere with the neurological action of Zoloft, Prozac and other SSRI antidepressants.

Some proponents of the new pill suggest FDAs hesitation isn't motivated so much by concerns over safety, but by a gender bias. The FDA has, of course, denied such claims.

"We live in a culture that has historically discounted the importance of sexual pleasure and sexual desire for women," Terry O'Neill , president of the National Organization for Women, told NPR. "And I fear that it's that cultural attitude that men's sexual health is extremely important, but women's sexual health is not so important. That's the cultural attitude that I want to be sure the FDA has not, maybe unconsciously, imported into its deliberative process."

Whitehead, a businesswoman, hasn't explicitly endorsed such a perspective, but she has hinted at an unfair discrepancy. She points out that there are several approved treatments for HSDD in men, but not a single drug yet approved for women.

But accusations of gender bias seem to ignore the fact that the drugs used to treat HSDD are decidedly different than the pill being submitted by Sprout. Viagra and the like use various mechanisms to increase blood flow to the penis. Flibanserin, on the other hand, intends to alter as many three major brain chemicals.

Still others are critical of the need to classify diminished sex drive as a clinically definable mental disorder -- likening it to previous attempts to pathologize homosexuality.

"The misrepresentation that everybody should be having it -- needs to have it, wants to have it, has a problem if they don't have it -- is to change, really, what sexuality is into more of a medical thing," Leonore Tiefer, a psychologist at New York University, told NPR. "I think that's a terrible direction for knowledge, for understanding, for society."

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