FDA Approves Addyi, Which Is Absolutely Not Viagra For Women

Image courtesy of (Curtis Perry)

Late yesterday, the Food and Drug Administration approved the drug flibanserin, which will hit the market under the brand name Addyi. You’ll see a lot of headlines and smirking news anchors using the phrase “Viagra for women” when talking about the drug, but that’s only correct in one sense. This drug wouldn’t be for sale to patients at all if it weren’t for the success of Viagra as a drug marketed directly to consumers.

Addyi works on the neurotransmitters dopamine and serotonin in the brain and not on blood flow to the genitals. It has to be taken daily, and works in a similar manner to popular antidepressants. That’s because it is one, or it was supposed to be. The first published animal studies on the drug appeared twenty years ago, but it apparently wasn’t all that promising as an antidepressant.

What it did have was a minor effect on the libido of female test subjects. Someone could sell that. It’s taken three attempts here in the U.S. and the better part of a decade, but after FDA approval, Addyi will go on sale in October. Medical providers will have to undergo training (an online video) before they can prescribe it.

One of the factors that helped the drug gain approval was the work of an alleged grassroots group. Even the Score accused the FDA of sex drug sexism for failing to approve any medications that treat Hypoactive Sexual Desire Disorder, an actual diagnosis defined as a recurring lack of sexual fantasies and desire in women who haven’t yet reached menopause, which causes the patient distress and problems in her relationship with her partner. Problems caused by a known medical condition or the side effects of a different medication do not count.

“There are 26 FDA approved drugs to treat various sexual dysfunctions for men (41 if you count generics!),” declares the website of Addyi booster Even the Score, “but still not a single one for women’s most common sexual complaint.” What none of those drugs do is treat day-to-day low sexual desire in men, and critics of Even the Score say that there are really only eight drugs on the market for erectile dysfunction. It’s pointless to “keep score” when the new drug treats a different problem and works on a different area of the body.

Drugs have side effects, though, and Addyi has some potentially dangerous ones: it can cause a sudden drop in blood pressure, fainting, and severe sleepiness, all of which can be worse when women take the drug along with alcohol or oral contraceptives. The drug performed better than placebo, but not by very much, and patients and their health care providers will have to decide whether the possible benefits are worth the possible risks. Addyi will cost $300 to $400 per month before insurance coverage.

FDA approves first treatment for sexual desire disorder [FDA]
Evening the score on sex drugs: feminist movement or marketing masquerade? [BMJ]
Women’s sex drug gets political hard sell [Politico]
Flibanserin: The Female Viagra is a Failed Me-too Antidepressant [Mad in America]
Even the Score: Women’s Sexual Health Equity [Official Site]

PREVIOUSLY:
FDA Closer To Approving Twice-Rejected Female Libido Drug

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