FDA Closer To Approving Twice-Rejected Female Libido Drug

Image courtesy of (Adam Gerard)

Yesterday, a Food and Drug Administration advisory panel recommended that the agency approve a new drug, flibanserin, which would be marketed under the brand name Addyi. In headlines and in news reports, you see references to the drug as a “pink Viagra” or “Viagra for women.” Yet the drug works on the brain, not the genitals, and critics say that its side effects may not be worth its proven benefits. The FDA has already rejected the drug twice.

Low sexual desire is a common problem, according to Sprout Pharmaceuticals, owner of flibanserin/Addyi. They estimate that one-third of women experience it, and for about 10% of women, the condition is actually distressing, causing problems in their lives and their relationships.

One of groups lobbying for approval of flibanserin or a similar drug is called Even the Score. They a gender-equality argument and accuse the FDA of sex drug sexism: “There are 26 FDA approved drugs to treat various sexual dysfunctions for men (41 if you count generics!),” declares the group’s website, “but still not a single one for women’s most common sexual complaint.”

In addition to medical associations such as the Association of Reproductive Health Professionals and the American College of Nurse-Midwives, the supporters of Even the Score include, yes, Sprout Pharmaceuticals.

During yesterday’s meeting, the FDA’s director of the division of bone, reproductive and urologic products countered that there are no approved drugs that solely treat low sexual desire in either men or women.

The condition that flibanserin is intended to treat is called Hypoactive Sexual Desire Disorder, defined as a recurring lack of sexual fantasies and desire in women who haven’t yet reached menopause. Critics say that the disorder was simply invented so that drug companies could invent treatments for it. With a potential market of 10% of all women required to take a pill every day, that’s a potentially lucrative market.

Researchers have tried different treatments for HSDD, and flibanserin has come the closest to FDA approval. Yet its possible side effects, which include dizziness, nausea, and dangerously low blood pressure, are worrisome. The main reason why flibanserin really isn’t LadyViagra is that it affects levels of neurotransmitters in the brain rather than the flow of blood to the genitals. It also has to be taken every day, not just before the patient plans to have sex.

“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,” one committee member told the New York Times. That means doctors would be required to undergo special training before they could prescribe the drug, and that patients would need special counseling before it’s prescribed for them.

Advisers To FDA Recommend Agency Approve Drug To Boost Female Libido [NPR]
‘Viagra for Women’ Is Backed by an F.D.A. Panel [New York Times]
Raleigh’s Sprout hears good news on women’s sexual dysfunction drug [Triangle Business Journal]
Even the Score: Women’s Sexual Health Equity [Official Site]

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