FDA approves drug for women with low sexual desire disorder

Henrietta Brewer
June 24, 2019

"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 Dr. Hylton Joffe, who directs the FDA's Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products.

The approval from the Food and Drug Administration adds another drug - the other is a daily pill that received FDA clearance in 2015 - meant to raise women's sexual desires.

The drug, bremelanotide, sold under the brand name Vyleesi by AMAG Pharmaceuticals, is an injection to be taken before sex. "Making women care less about the bad sex that they're having is a dubious goal".

The pharmaceutical industry has pointed to surveys in recent years that indicate the sexual disorder is the most common among females across the nation, affecting one in 10 women.

"Female sexual dysfunction is more complicated in some ways than male sexual dysfunction, so it's more hard to treat", said Dr. Nicole Cirino, co-director of the Menopause and Sexual Therapy Clinic at Oregon Health and Science University's Center for Women's Health. Vyleesi is only the second FDA-approved medication to increase women's sex drives.

Vyleesi's demonstrated increases in reported desire, measured on a five-point scale, are small.

Side effects can occur, the FDA added, and include nausea and vomiting, flushing, injection site reactions and headache.

The company, which manufactures other products for women's health, estimates that almost six million American premenopausal women suffer from low sexual desire, a condition that largely goes untreated.

Kingsberg, a clinical psychologist, said that "the impact of sexual dysfunction on a woman's self-esteem, on her body image, on her self-confidence and on her relationship is profound".

Addyi never really took off, partly because it is a daily pill that takes a while to work, and the product carries a "black box" label that warned of serious side effects such as dizziness and low blood pressure when the drug was taken with alcohol. The advantage of Vyleesi is it can be used as needed.

AMAG Pharmaceuticals, which manufactures the drug, welcomed the FDA's decision.

US health regulators have approved a prescription drug to boost sex drive in women. She had no role in Vyleesi's development.

Vyleesi will join Addyi in women's small list of drug options that can boost their libido.

"I think it's worth noting what's an acceptable level of libido is socially influenced", said Dr Adriane Fugh-Berman, a professor in the department of pharmacology and physiology at Georgetown University Medical Center who studies pharmaceutical marketing.

The effectiveness and safety of Vyleesi were studied in two 24-week, randomized, double-blind, placebo-controlled trials in 1,247 premenopausal women with acquired, generalized HSDD. To them, prescribing a drug for HSDD misguidedly reduces the complexity of human sexuality to a biological issue.

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