FDA Approves Medication to Treat Female Sexual Disorder

The Food and Drug Administration (FDA) on Friday approved Vyleesi (bremelanotide) to treat premenopausal women for acquired, generalized hypoactive sexual desire disorder (HSDD). HSDD (classified as female sexual interest/arousal disorder in DSM-5) is characterized by low sexual desire that causes distress and cannot be explained by a comorbid physical or psychiatric illness, the side effects of substance use or medications, or severe relationship problems. Acquired HSDD means a woman has previously experienced sexual desire (it has not been a lifelong problem).

“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,” said Hylton V. Joffe, M.D., M.M.Sc., director of the FDA’s Division of Bone, Reproductive, and Urologic Products in the agency press release. “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.”

The approval of Vyleesi was supported by two 24-week, randomized clinical studies involving 1,247 premenopausal women with HSDD. In both trials, Vyleesi was more effective than placebo at improving patient-reported sexual desire and reducing emotional distress. Vyleesi is not approved to enhance sexual performance, and women should not use more than one dose every 24 hours or more than eight doses per month, according to the FDA statement.

The most common side effects of Vyleesi are headache, nausea, skin flushing, and reactions at the injection site. The medication can temporarily increase blood pressure, so it should not be taken by women with uncontrolled hypertension or those at high risk of cardiovascular disease. Vyleesi should also not be taken by women taking oral naltrexone (used to treat alcohol use disorder and opioid use disorder), as this medication interferes with naltrexone activity.

To achieve the desired effects of Vyleesi, women are advised to inject the medication into their abdomen or thigh at least 45 minutes before anticipated sexual activity. The medication is known to activate receptors for the hormone melanocortin, but the mechanism by which it improves sexual desire and reduces related distress is unknown.

As noted in a statement by AMAG Pharmaceuticals, manufacturer of Vyleesi, the medication is not indicated for treatment of HSDD in men and postmenopausal women. The medication will be commercially available in September at select pharmacies.

For related information, see the Psychiatric News article “Experts Continue to Debate if Addyi Benefits Outweigh Risks.”

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