FDA Approves New Option for Hypoactive Sexual Desire Disorder

The FDA has approved Vyleesi (bremelanotide) for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.

The drug works by activating melanocortin receptors, although the mechanism by which it improves sexual desire is unknown. It is injected under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity and should not be used more than once within 24 hours, or more than 8 times in 1 month.

The safety and effectiveness of the injection were evaluated in two 24-week randomized, double-blind, placebo-controlled trials involving 1247 postmenopausal women. About 25% of patients treated with Vyleesi saw increases of 1.2 or more in their sexual desire score, compared to about 17% of those taking placebo. Further, about 35% of those taking Vyleesi had a decrease of 1 or more in distress score compared with about 31% of those taking placebo.

The most common side effects included nausea, vomiting, flushing, injection site reaction, and headache.

—Michael Potts

Reference:

FDA. FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women [press release]. June 21, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hypoactive-sexual-desire-disorder-premenopausal-women.