‘Women’s Viagra’ Gets OK From FDA Committee

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The first drug designed to boost a woman’s sex drive was given the green light Thursday by a government advisory panel, which recommended that the pill be approved by the Food and Drug Administration, but only with certain safety restrictions.

The committee voted 18-6 in favor of approving the pill flibanserin for women on the condition that drugmaker Sprout Pharmaceuticals take measures to reduce the risk of its side effects.

The FDA is expected to announce a final decision by the end of the summer.

“I am elated, very happy to hear this,” Margery Gass, M.D., a sexual dysfunction expert at Cleveland Clinic, told CNN after Thursday’s vote. “I think women are going to be very appreciative of having something they can try for this problem.”

Others weren't so sure. Adriane Fugh-Berman, M.D., an associate professor of pharmacology and physiology at Georgetown University, called the drug “a mediocre aphrodisiac with scary side effects,” the New York Times reported. She said that the drugmaker’s clinical trials were restricted to healthy women, but that if approved, the drug would be used by a wider range of women, resulting in “an epidemic of adverse events.”

Flibanserin previously was rejected in 2010 and 2013 for what the committee said were minimal benefits outweighed by worrisome side effects that could include fainting, fatigue, dizziness and nausea. The daily pink pill is aimed at premenopausal women with low libido, even though more than half of postmenopausal women also complain of the problem.

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Just how much better were women's sex lives after taking the pill? In three clinical trials, women reported they were having an average of two to three “sexually satisfying events” per month before going on the drug. After taking the drug, the number of these events increased, but by no more than one per month, as compared to a placebo.

That's not exactly a huge improvement, but committee member Tobias Gerhard, an expert on drug safety at Rutgers University, said, “The unmet need seems to be so strong that even for a drug with rather modest benefit, I think approving the product with strong limitations seems to be the right step at this point,” the Times reported.


The pill’s most recent rejection had sparked a controversial campaign — called Even the Score — by Sprout and a number of women’s groups, who accused the FDA of gender bias for approving sex drugs for men but not for women. But other experts, including the National Women’s Health Network, said it wasn’t a matter of sexism but of problems with the drug itself that had caused the rejection.

FDA officials also firmly rejected the gender bias claim, saying no drugs for either men or women had been approved to treat loss of sexual desire, which is not the same as drugs for men’s erectile dysfunction.

Although dubbed “women’s Viagra,” flibanserin works in a very different way than Viagra for men. In men, Viagra increases blood flow to the penis to achieve erection. In women, it’s not a problem of blood flow, but of brain chemistry not triggering desire. Flibanserin, which was originally tested as an antidepressant, targets the brain neurotransmitters that affect arousal and desire.

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Before Thursday’s vote, the panel heard emotional testimony from women who suffer from a lack of sexual desire, despite being otherwise healthy.

During the hearing, Sprout Pharmaceuticals said 46 to 60 percent of the women in clinical trials had benefited from the flibanserin treatment. But some committee members pointed out that, after adjusting the data to take the placebo effect into account, the drug wound up helping only about 10 percent of the women, the Washington Post reported.

FDA officials were also worried about a cancer trial that found an increased risk of breast tumors in mice given a high dose of the drug. One advisory panel member called the potential link to cancer a “show stopper,” according to the Post.

Fugh-Berman urged the FDA to resist being pressured to approve the drug by the Even the Score campaign, saying it would "set the worst kind of precedent — that companies that spend enough money can force the FDA to approve useless or dangerous drugs."


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