FDA approves controversial female libido drug

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The US Food and Drug Administration has approved a controversial drug meant to increase women’s desire for sex, a treatment that has rekindled a debate over the limits of medicine when it comes to human sexuality. Stat News reports that the drug, called Vyleesi, is an under-the-skin injection that women can take before sex. It’s approved for women with hypo-active sexual desire disorder, or HSDD, which is defined as a distressing loss of interest in sex.

Vyleesi’s demonstrated increases in reported desire, measured on a five-point scale, are small. But, the report says, AMAG Pharmaceuticals, the drug’s manufacturer, contends that even a seemingly marginal improvement can make a major difference for women with HSDD. The drug’s most common side effect is nausea, which affected 40% of women in clinical trials, and the FDA advises women against taking more than one dose within 24 hours or more than eight doses per month.

AMAG did not disclose how much it would charge for Vyleesi.

The report says sceptics of drugs like Vyleesi balk at the idea of a pharmaceutical product playing a role in sexual desire. To them, prescribing a drug for HSDD misguidedly reduces the complexity of human sexuality to a biological issue.

Vyleesi is the second treatment for HSDD cleared for marketing in the US, following the pill Addyi, which was approved in 2015. Addyi, made by Sprout Pharmaceuticals, never took off commercially, in large part because of a black-box safety warning that prohibited women from drinking alcohol before taking it.

The report says analysts don’t expect Vyleesi to fare much better. The drug does not have Addyi’s safety concerns, but the fact that it must be injected could be a major barrier to potential patients, according to SVB Leerink analyst Ami Fadia. Ken Cacciatore, an analyst at Cowen, wrote in a note to investors that he expects Vyleesi’s commercial performance to “materially disappoint.”

The report says AMAG has spent the past few months trying to spread the word about HSDD ahead of Vyleesi’s approval, launching informational websites targeting patients and providers. The condition is the most common sexual dysfunction affecting women, but many patients and doctors are unaware of HSDD, much less any treatment for it, according to the company.

Stat News report

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