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New ‘Female Viagra’ Is FDA-Approved, but the Data Is Shaky

Vyleesi promises a higher sex drive, but critics say there’s not enough peer-reviewed data to back it up.

New ‘Female Viagra’ Is FDA-Approved, But the Data Is Shaky
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Last week, the Food and Drug Administration approved a new drug meant to boost sexual desire in women. It’s been billed as “female Viagra” by multiple sources since the news broke, but Vyleesi (the generic drug name of bremelanotide) actually tackles the issue of sexual dissatisfaction in a very different way than Viagra (sildenafil citrate) does for men.

Viagra, first approved by the FDA in 1998, relieves erectile dysfunction by boosting the effects of nitric oxide, which increases blood flow to the penis and helps a man get and maintain an erection, according to the Mayo Clinic. In other words, it’s purely physical—Viagra isn’t going to get a man “in the mood.”

Vyleesi, on the other hand, is meant to treat a condition known as hypoactive sexual desire disorder (HSDD). The American Sexual Health Association defines HSDD as “the absence of sexual fantasies and thoughts, and/or desire for or receptivity to sexual activity that causes the personal distress or difficulties in her relationship.”

The FDA admits that it’s unclear how Vyleesi works exactly; just that it activates melanocortin receptors in the brain, improves sexual desire, and relieves the distress related to a low libido. It’s the second drug to be approved for female sexual dysfunction, with the first being Addyi (flibanserin) in 2015.

Also meant to raise women’s overall libido, Addyi has a few drawbacks, including the commitment to take a pill every day and potentially serious complications when it’s combined with alcohol. Vyleesi is an injection, which isn’t great for those uncomfortable with needles, but it only needs to be taken before sex. It’s also safe to use it with alcohol, according to the New York Times.

The drug was studied in two 24-week, randomized, double-blind, placebo-controlled trials, including 1,247 premenopausal women struggling with HSDD. About 25 percent of the participants self-reported increased sexual desire while using Vyleesi, compared to 17 percent of the placebo group. About 35 percent reported less personal distress, compared to 31 percent in the placebo group. Forty percent of the participants reported nausea, especially with the first injection. It’s also not recommended for women with high blood pressure.

Critics have voiced concerns that the drug hasn’t been scrutinized enough.

“It is unfortunate that the FDA decided to approve this drug despite the skimpy peer-reviewed data and complete lack of long-use safety information,” Diana Zuckerman, president of the National Center for Health Research, told the Washington Post. “The good news is that it doesn’t need to be taken every day, the way Addyi does. The bad news is that the public can’t have confidence in the safety of the drug because we don’t have access to long-term safety information about it.”

Some are also questioning the way the drug is meant to work. A low libido is a complicated issue, and HSDD is an issue that’s mostly promoted by the very companies that produce the drugs meant to “fix” it.

Either way, the FDA moved forward with the drug’s approval, so we’ll find out in time whether it’s the female libido booster it’s billed to be. For the FDA’s part, it aims to help women address the concerns that come along with HSDD.

“There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment. Today’s approval provides women with another treatment option for this condition,” Hylton V. Joffe, M.D., M.M.Sc., director of the Center for Drug Evaluation and Research’s Division of Bone, Reproductive and Urologic Products, said in a statement. “As part of the FDA’s commitment to protect and advance the health of women, we’ll continue to support the development of safe and effective treatments for female sexual dysfunction.”

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