Vyleesi (bremelanotide) is a drug used to treat general, acquired hypoactive sexual desire disorder (HSDD) in premenopausal women. [Note: HSDD is sometimes called female sexual interest/arousal disorder (FSIAD).]
Women with HSDD have a persistent lack of interest in sex that can’t be easily explained by other medical conditions, psychological factors, or drug side effects. This lack of desire causes distress. Acquired means that the situation started after a period of normal sexual desire. Generalized means that low desire occurs in all sexual situations, with all partners.
Vyleesi is an injectable drug that women can administer themselves at home. Each dose is contained in a single-dose autoinjector pen and injected into the thigh or abdomen, just under the skin.
The drug is used on an as-needed basis. Women are advised to take Vyleesi about 45 minutes before they expect to have sex, although this time frame can be changed as needed.
Patients should not take more than one dose of Vyleesi within 24 hours, and they should not take more than eight doses each month.
To evaluate the effectiveness and safety of Vyleesi, scientists conducted two 24-week clinical trials involving 1,247 premenopausal women with acquired, generalized HSDD.
Overall, they found that 25% of the women who used Vyleesi experienced increased sexual desire, compared to 17% of the women who took a placebo drug.
About 35% of those who took Vyleesi reported less distress. For women who took a placebo, the figure was 31%.
At the end of the studies, the women had similar numbers of satisfying sexual events, regardless of whether they used Vyleesi or the placebo.
Nausea is one of the most common side effects of Vyleesi. In fact, about 40% of women in clinical trials reported nausea, often after the first injection.
Other common side effects are:
- Injection site reactions
In clinical trials, about 1% of women experienced a darkening of the gums and some skin areas such as the face and breasts. For about half of these women, this situation did not improve after stopping the medication. This side effect was more common in dark-skinned women.
Vyleesi is not appropriate for women with certain health conditions, including cardiovascular disease or uncontrolled high blood pressure. Women at high risk for cardiovascular disease should not use Vyleesi.
In addition, women who take oral naltrexone for alcohol or opioid dependence should not use Vyleesi.
Vyleesi is not intended for women who have gone through menopause.
If you are struggling with low libido and wondering if Vyleesi is right for you, talk to your healthcare provider. He or she can help determine what factors, if any, might be contributing to low sex drive and whether an HSDD diagnosis is appropriate.
Some women with HSDD also benefit from counseling or sex therapy.
For more information about HSDD and low sex drive, please see these links:
“Sex Drug for Women Stirs Up Controversy in Medical Community”
(August 23, 2019)
“A New Sex Drug for Women? 6 Things You Need to Know About Vyleesi”
(July 19, 2019)
Park, Brian, PharmD
“Vyleesi Now Available to Treat Hypoactive Sexual Desire Disorder”
(August 30, 2019)
“FDA Approves Vyleesi for Women with HSDD”
(June 24, 2019)
U.S. Food and Drug Administration
“FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women”
(Press release. June 21, 2019)