FDA on ‘female Viagra’: FDA Approval Flibanserin

Published: August 18, 2015

FDA on ‘female Viagra’: FDA Approval Flibanserin, The Food and Drug Administration will decide the fate of a drug to treat low libido in women by Tuesday.

Depending on your point of view, the “little pink pill,” flibanserin – popularly but incorrectly dubbed the “female Viagra” – is either the answer to a woman’s prayers or a risky drug that turns a normal condition into a medical problem that only pharmaceuticals can solve.

It will be FDA’s third consideration of flibanserin in five years. The agency has rejected the drug twice since 2010.

This time around, the drug is benefiting from a major public relations push from an advocacy group, Even the Score, which is supported by flibanserin’s manufacturer, Sprout Pharmaceuticals of Raleigh, N.C. High-profile supporters include the National Organization for Women and 11 members of Congress who wrote to the FDA on flibanserin’s behalf.

Dozens of women filled FDA hearing rooms at meetings over the past year, testifying about the anguish and marital turmoil caused by their loss of sex drive. Sprout’s CEO, Cindy Whitehead, has acknowledged that her company paid for many of the women’s travel expenses.

“It’s important to put the patient voice at the center of the discussion,” Whitehead said in an interview.

In June, an FDA advisory panel voted to recommend approval of flibanserin, provided that Sprout take certain steps to limit the pill’s risks.

But critics say Sprout is using its publicity campaign to make up for weaknesses in the drug, arguing that the science behind flibanserin hasn’t changed since the last time the FDA rejected it.

About 200 health professionals signed open letters to the FDA in July, arguing that flibanserin is little better than a placebo when it comes to improving libido, and its side effects could endanger women’s health.

“Approving flibanserin will not only unleash an unsafe drug onto the U.S. market, but will send a message to industry that pressuring the FDA through public relations campaigns can get a drug approved,” said one of the letters, whose lead author was Adriane Fugh-Berman, an associate professor at Georgetown University Medical Center in Washington and director of its PharmedOut program, which critiques pharmaceutical industry marketing.

Fugh-Berman questioned whether the women in the flibanserin studies were experiencing a real medical problem or simply the fluctuations of libido that commonly occur as women age and cope with the fatigue caused by work, motherhood and other demands. Some of the women’s distress could be caused not by the women’s lack of sex drive, but from a mismatch between their libido and that of a partner interested in having a lot more sex, Fugh-Berman said.

In clinical trials of flibanserin, women experienced two to three “satisfying sexual events” per month before joining the study. Compared to women given a placebo, those taking flibanserin had an average of 0.5 to 1.0 additional satisfying sexual events per month, according to an FDA analysis.

Sprout’s marketing of flibanserin “is medicalizing a normal condition,” Fugh-Berman said. “Do we really need to have a corporately determined level of libido?”

Advocates for flibanserin note that one in 10 women suffer from low libido, a problem that the FDA lists as an area of “unmet need” in medicine.

On its website, Even the Score takes the FDA to task for approving Viagra and other drugs that improve men’s sex lives, without approving drugs to help women.

In a letter to the FDA, Rep. Jackie Speer, D-Calif., and 10 other members of Congress wrote, “We firmly believe that access to health care should be a fundamental right, regardless of whether you are a man or a woman.”

FDA officials have defended their record, however, noting that flibanserin is not, as some have claimed, a female equivalent of Viagra.

Viagra treats erectile dysfunction, not low libido. At a June hearing, the FDA’s Hylton Joffe said there are no approved drugs for low libido in either women or men.

Flibanserin’s manufacturer agrees that its medication works very differently than drugs that help men achieve erections.

For women, “it’s not about blood flow,” Whitehead said. “Desire is happening in the brain.”

Unlike Viagra, which men take before sex, women would take flibanserin every day for the rest of their sex lives. Sprout has asked the FDA to approve flibanserin for premenopausal women whose lack of sex drive is not caused by a medical or mental health condition or by a medication, such as antidepressants. Flibanserin isn’t designed to treat vaginal dryness that can make intercourse painful.

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