Bremelanotide Approved for Hypoactive Sexual Desire Disorder in Women

By Kelly Young

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The FDA has approved bremelanotide (Vyleesi) to treat premenopausal women with acquired, generalized hypoactive sexual desire disorder.

In trials of 1200 women, those who used bremelanotide — injected under the skin of the abdomen or thigh at least 45 minutes before sexual activity — had improved sexual desire scores compared with placebo patients (25% vs. 17%).

The FDA notes that patients shouldn't use more than one dose a day or eight doses a month. They should stop treatment at 8 weeks if they don't notice any improvement in sexual desire and distress.

Roughly 40% of patients in the studies experienced nausea, often with the first injection. About 1% experienced darkening of the gums and skin (bremelanotide activates melanocortin receptors that are widely expressed in the brain). The drug is also associated with increased blood pressure that usually resolves within 12 hours, so it shouldn't be used in patients with uncontrolled hypertension or cardiovascular disease or in patients at risk for CVD. It is also contraindicated in patients taking oral naltrexone for opioid or alcohol use disorder.