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Flibanserin or Female Viagra gets FDA nod

Flibanserin or Female Viagra gets FDA nod

A drug aimed at helping women who’ve lost their sex drive cleared a key hurdle Thursday, winning backing from a Food and Drug Administration panel.

An FDA advisory committee voted 18-6 to recommend that the agency approve the drug flibanserin for the treatment of hypoactive sexual desire disorder in premenopausal women.

The panel’s recommendation will be given to the FDA, which will ultimately decide whether to approve the drug, frequently referred to as “female Viagra” because it’s a pill for sexual dysfunction in women. The FDA often follows the recommendations made by advisory committees but is not required to do so.

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

‘It’s complex’

There’s no doubt that sex drugs for men have been a boon for the pharmaceutical industry. The FDA approved Viagra in 1998. And last year, the drug earned more than $1.6 billion for Pfizer.

But drug companies have struggled to come up with the right formula for women.

Why?

According to a 2002 study, up to one-third of adult women might experience hypoactive sexual desire disorder — the technical term for when women have a lack or absence of sexual desire or fantasy.

But some experts say that for women, the cure for low libido is more likely to be found in their brains than in a bottle.

“Women’s sexuality is very complicated. It’s not a matter of just taking that pill by the way, and then all of a sudden the lights go on,” said Judy Kuriansky, a clinical psychologist and certified sex therapist. “You have to feel good about your body. You have to feel good about yourself. You have to feel the guy really loves you. … It’s complex. It’s not the same as a man taking a pill.”

 Even though it’s being dubbed as “Viagra for women,” experts say it’s a misnomer to describe flibanserin that way since the way the drug works is distinctly different.

It’s a drug that works on the central nervous system — in the same category as an antidepressant.

Viagra, in contrast, focuses on the physical, treating erectile dysfunction but doing nothing to induce sexual desire.

Third review by FDA

Thursday’s meeting was the third time the FDA has reviewed flibanserin, made by Sprout Pharmaceuticals.

In the past, the FDA has rejected it, saying it had too many side effects, and really didn’t turn women on anyhow.

In 2010, a committee told pharmaceutical giant Boehringer Ingelheim, which initially developed the drug, that the company should go back to the drawing board to develop more conclusive data about it. In 2013, the drug was rejected without going before the committee.

Last year, Sprout Pharmaceuticals said it was preparing to conduct additional studies after the FDA had given the company “clear guidance” on “the path forward.”

A 2013 study in The Journal of Sexual Medicine showed that women taking the drug reported an average increase of 2.5 satisfying sexual events in four weeks, compared with an increase of 1.5 among women using a placebo.

Gender disparity?

In the days leading up to this week’s vote, Sprout Pharmaceuticals has been part of a campaign making the case that the FDA hasn’t done enough to help women dealing with sexual dysfunction.

The campaign, called “Even the Score,” has argued there’s been a significant gender disparity in the drugs that the FDA has approved.

That’s a claim the FDA strongly denies.

“The FDA strives to protect and advance all important areas of women’s health,” FDA spokeswoman Andrea Fischer said, “including disorders of female sexual function.”

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