Regulators OK injectable med to bolster women's sex drive
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Federal regulators approved a medication Friday to boost low sex drive for women that comes in the form of a shot to the thigh or abdomen.
The approval from the Food and Drug Administration adds another drug — the other is a daily pill that received FDA clearance in 2015 — intended to raise women's sexual desires. Viagra for men has been around since the 1990s.
The developer for the women's drug, Amag Pharmaceuticals, declined to release pricing information.
The drug, bremelanotide, will be marketed under the name Vyleesi, the FDA said in a statement. It will be used to treat premenopausal women with a hypoactive sexual desire disorder, which is defined by a persistent lack of interest in sex, causing stress. Side effects include nausea, vomiting, injection site reaction and headaches.
This image provided by Amag Pharmaceuticals in June 2019 shows packaging for their drug Vyleesi. The medication OK’d Friday, June 21, 2019 by the U.S. Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drugmakers have been trying to cultivate since the blockbuster success of Viagra for men in the late 1990s. (Amag Pharmaceuticals via AP)
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.
Women with high blood pressure or heart disease should not take the drug because blood pressure increases were observed during testing. The approval was based on women's responses to questionnaires that showed increases in sexual desires and decreases related to stress.
The women didn't report having more sex.
"Women are not desiring more sex. They want better sex," said Dr. Julie Krop, Amag's chief medical officer.
It's unclear how many women could benefit from the drug without full clinical trials. Around 20 percent of women dropped out early, Bloomberg reported. Waltham, Massachusetts-based Amag said nearly 6 million women meet the criteria for the drug.
Vyleesi acts on receptors for a brain-stimulating hormone called melanocortin, which is associated with sexual arousal and appetite in both men and women. The drug would the second female libido medication on the market. Addyi, a once-a-day pill, was cleared by the FDA in 2015 after a four-year review process.
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Many accused the agency of being sexist when it first rejected the drug in 2013. Most insurers refused to cover the drug. Women balked at the $800 monthly costs last year, which was lowered to $400.
Amag plans to market Vyleesi through social media and a website, unblush.com, that tells women having a low sex drive "is nothing to blush about."
The Associated Press contributed to this report.
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