FDA Approves New Libido-Boosting Drug for Women

The United States Food and Drug Administration (FDA) has approved a new treatment for women suffering from loss of sexual desire, which comes after the marketing of a well-known pill was allowed in 2015 as the “female Viagra”.

Vyleesi (bremelanotide), indicated to be injected at least 45 minutes before sexual activity, was approved to treat acquired generalized hypoactive sexual desire disorder (HSDD) in premenopausal women, the FDA said in a statement.

The drug, according to the US agency, “activates the melanocortin receptors,” although “the mechanism by which it improves sexual desire and related distress” is unknown.

Among the side effects, the FDA mentioned nausea, vomiting, flushing, injection site reactions and headache.

Vyleesi, which will be distributed by AMAG Pharmaceuticals, caused an increase in blood pressure after its application that was resolved in 12 hours, explained the FDA, commenting on the results of the clinical trials.

In this context, the agency warned that, due to this effect, the drug “should not be used in patients with high blood pressure that is not controlled or in patients with known cardiovascular disease.”

The FDA also warned that this drug can significantly reduce the levels of naltrexone taken orally, used in patients with alcohol dependence or opioids, which can lead to treatment failure.

In August 2015, the FDA authorized the pharmaceutical company Sprout Pharmaceuticals to put flibanserin on sale since October of that year, under the brand name Addyi.

The medication is intended to be administered daily to premenopausal women who suffer from a sexual anorexia disorder, that is, the sudden loss of any desire to have sex.

The approval of Addyi was not as well received in the scientific community, since numerous doctors and pharmacologists questioned at that time not only the effects of the medication, but the very nature of the supposed sexual disorder.

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