Update: As of Saturday, flibanserin — the so-called "female Viagra" and the first drug designed to increase libido in either women or men — has hit shelves under the name "Addyi." If women can get beyond its drawbacks (dizziness, fatigue, nausea; possible spontaneous fainting; no alcohol allowed), Addyi is shown to lead to "0.5 to 1" more "sexually satisfying events" per month than women on a placebo. Per the FDA, the drug can only be prescribed by doctors who have been specially trained by Sprout Pharmaceuticals, the drug's maker, and doctors will be required to track the experiences of patients who use it. It's clear that the FDA prefers that the "little pink pill" be used as a last resort, but now, it's up to women to decide.
This story was originally published on August 18, 2015.
The FDA has just announced its decision to approve the controversial drug flibanserin, produced by Sprout Pharmaceuticals to treat Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women. This verdict was widely predicted after an FDA advisory committee voted 18-6 to recommend approval — and it comes after two previous rejections of flibanserin, in 2010 and 2013. At both of those points, the FDA called for further research to confirm that the drug's benefits justified its side effects (including fainting, nausea, and dizziness) and that these side effects stopped short of dangerous. It's not often that an applicant appeals an FDA rejection, but the second time around, Sprout did. It also assembled 24 organizations, including the National Organization for Women and the Association of Reproductive Health Professionals — as well as a handful of pharmaceutical companies — in an ambitious campaign to re-frame flibanserin's approval as an issue of women's health equity, and to rally public support for the drug. Even The Score's battle cry was this: While men have access to 26 drugs to treat sexual dysfunction (though the FDA has only approved nine, none of which treat low desire in isolation), women have access to none. "We're very content to reduce all things in the bedroom for women to psychology, and all things in the bedroom for men to biology," Sprout Pharmaceuticals co-founder Cindy Whitehead asserted at a May press event, arguing that low female libido can be a medical condition independent of anxiety or depression and should be treated as such. The first medication that aims to increase women's sex drive by adjusting brain chemistry instead of hormone levels, flibanserin acts on the neurotransmitters dopamine, norepinephrine, and serotonin and is meant to be taken every day. "Female Viagra," as the drug has been dubbed, is a misnomer, since Viagra works by increasing blood flow to the genitals and is meant to be taken shortly before sex. Flibanserin has attracted both fervent support and detraction, even within the medical community. The debate centers not only on how well it works (the answer is: modestly, at best — women on the drug reported "0.5 to 1" more "sexually satisfying events" per month than women on a placebo) but also on whether the drug represents a threatening step toward the medicalization of female sexual desire. "Hypoactive Sexual Desire Disorder was actually invented by pharmaceutical companies," Adriane Fugh-Berman, MD, the director of pharmaceutical watchdog project PharmedOut, testified to the FDA advisory committee that recommended flibanserin's approval. "Certainly there are women that have low libido, but that can be caused by many different things, including medications, such as the birth control pill and antidepressants and blood pressure medicines, for example." Dr. Fugh-Berman also described flibanserin as "a mediocre aphrodisiac with scary side effects." Advisory panel member Amy Whitaker, MD, assistant professor at the Department of Obstetrics and Gynecology at the University of Chicago, was more generous and yet still hesitant in her assessment: "It’s exciting we’ll have this in our armorarium," she stated after casting her vote in support of approval, "but we all wish it was a better drug." After today's momentous decision, American women can decide for themselves just how effective the drug is.