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FDA approves sex drug for women that only kinda works

Son of Groucho

The first-ever pill for low libido in women won approval for sale from US regulators. The once-daily drug, made by Sprout Pharmaceuticals and to be marketed as Addyi (pronounced "add-ee"), will be on the market in October, the company said in a statement.

Sadly, the drug doesn't work that well. Somewhere between 8 and 13 percent of women who take the drug daily experience an average of 0.5 more "sexually satisfying" events per month. That's... not much. And its side effects include drowsiness, dizziness, and fainting.

The FDA rejected the drug twice before today The scant benefit, along with the side effects, may be why the US Food and Drug Administration rejected the drug twice before today. A panel in June recommended putting the pill — then known by its chemical name, flibanserin — on the market with an 18–6 vote, with certain safety warnings. "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," Tobias Gerhard, a drug safety expert and member of the panel, told The New York Times in June.

What may have influenced the panel was the company's "Even the Score" campaign, since no new tests were performed since the most recent rejection in 2013. "There are 26 FDA approved drugs to treat various sexual dysfunctions for men," the Even the Score website reads, "but still not a single one for women's most common sexual complaint." This conflates, somewhat, what the drugs for male sexual dysfunction and Addyi do; there are no drugs for low male libido. Pfizer's Viagra, for instance, treats erectile dysfunction, not the absence of desire in the first place.

No new tests were performed since the most recent rejection Addyi was originally developed as an antidepressant but it failed to show efficacy, according to a report in the Journal of the American Medical Association. But some test subjects recorded a higher libido — suggesting a new development path. Addyi is approved for "hypoactive sexual desire," which is described by the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders — the mental health Bible — as a "persistently or recurrently deficient or absent sexual fantasies and desire for sexual activity" that can't be explained by outside factors like another health condition, medication side effects, or severe relationship stress. The FDA considers this an area of unmet medical need.