A Female Libido Drug Rejected by the FDA Is Being Retested

Two months after the Food and Drug Administration rejected a pill to treat low sexual drive in women, the drug’s maker, Sprout Pharmaceuticals, has agreed to conduct additional testing on the product. If approved, flibanserin would be the first drug on the market to treat female hypoactive sexual desire disorder.

The Raleigh (N.C.)-based company must conduct three studies, as demanded by the FDA, on whether flibanserin impairs driving, how it interacts with other drugs, and how it’s metabolized in the liver. Sprout—which currently makes no other drugs—expects to complete testing and resubmit an application during the third quarter this year. The FDA then has six months to review and make a decision, says Sprout Chief Operating Officer Cindy Whitehead, who heads the company with her husband, Bob.

A few key things to know about flibanserin: It’s for premenopausal women. It’s a once-a-day pill. It works by stimulating the release of the neurotransmitters norepinephrine and dopamine, and suppressing serotonin, which is associated with happiness, but can actually decrease desire and delay orgasm if there’s too much of it, according to Sprout. Whitehead says this is very different from so-called “beer goggles.” While alcohol can reduce inhibition, she says, it won’t address the biological causes for lack of sex drive.

About 45 percent of women in one study said the drug had some positive effect (their libido was “very much,” “much,” or “minimally” improved), though it can take one month for the user to experience any change. Whitehead says it’s not like Viagra, where there’s an on-demand response, and it does not result in hypersexuality. Rather, it feels more like a general “reawakening” of desire. “Women will say, we were out to dinner for date night and I couldn’t wait for the check to come. Or, I was driving in the middle of a workday and I’ll want to send a sexy e-mail,” she says. The drug would likely be prescribed by OB-GYNs, psychiatrists, and other physicians who specialize in sexual disorder, according to Whitehead.

The side effects of Sprout’s flibanserin pill include dizziness, nausea, fatigue, and sleepiness. As about 10 percent of women experienced sleepiness, the company recommends using the drug at bedtime (though doesn’t being too sleepy in bed seem like its own challenge to one’s sex life?).

Sprout acquired the rights for flibanserin from Boehringer Ingelheim in 2011 after the FDA told the Germany-based drugmaker that the treatment hadn’t been proven safe or effective, according to Bloomberg News. Sprout has not altered the drug since acquiring it but has conducted additional testing.

The FDA, which only provides information on approved drugs, declined to comment on flibanserin, but said in an e-mailed statement: “FDA maintains the highest vigilance to protect and advance the health of women, and we are committed to helping companies develop safe and effective treatments for female sexual dysfunction.”

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