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FDA Approves Vyleesi for Women with HSDD

The U.S. Food and Drug Administration (FDA) has approved a drug called Vyleesi for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.

HSDD is a lack of sexual desire that can’t be explained by other medical or psychiatric conditions and causes distress. In addition, HSDD is not related to relationship conflict or medication side effects. It can be frustrating for both women and their partners, who may have enjoyed a satisfying sexual relationship before.

Vyleesi (bremelanotide) has been approved for women with acquired, generalized HSDD. This means that the HSDD occurs after a period of normal sexual functioning and that it happens in all sexual situations, not just every once in a while or with specific partners.

Vyleesi works by activating cells called melanocortin receptors, but scientists aren’t sure why it helps with desire and distress. The drug is injected under the skin of the thigh or abdomen about 45 minutes before sex, although this time frame may be adjusted based on personal experience.

Women should not use Vyleesi more than once every 24 hours and should not take more than 8 doses per month.

To test Vyleesi’s effectiveness and safety, scientists conducted two clinical trials involving 1,247 premenopausal women with HSDD. About a quarter of the women who took Vyleesi had improvements in desire. For women who took a placebo, the rate was 17%.

About 35% of the women who took Vyleesi saw their distress levels go down as well, compared to 31% of the placebo group.

Both groups had similar rates of satisfying sexual events.

In the trials, nausea seemed to be the biggest side effect of Vyleesi, affecting about 40% of women. Some women reported flushing, injection site reactions, and headache. About 1% of the women developed darkened gums and parts of the skin, including their face and breasts.

Experts advise against the use of Vyleesi in these circumstances:

  • If women have uncontrolled high blood pressure, known heart disease, or a high risk for heart disease. Blood pressure may increase after taking Vyleesi, although it usually goes back to normal within 12 hours.
  • If women take naltrexone-containing medication by mouth. Vyleesi can decrease levels of naltrexone, a drug used to treat alcohol and opioid dependence.

Vyleesi should go on sale later this year, according to a New York Timesreport.

Another drug, Addyi (flibanserin), was approved for some women with HSDD in 2015. (See recent news about Addyi here.)


The New York Times

Thomas, Katie

“New Sex Drug for Women to Improve Low Libido Is Approved by the F.D.A.”

(June 21, 2019)

U.S. Food and Drug Administration

“FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women”

(Press release. June 21, 2019)