Vyleesi (Viagra for women) approved by FDA

The United States Food and Drug Administration ( FDA ) approved the sale of a new drug (so-called female Viagra) despite the skepticism of the medical community writes The Washington Post.

“There are women who, for unknown reasons, have reduced sexual desire. This condition causes distress. Such women can benefit from safe and effective pharmacological treatment” said Hilton Joff, director of the FDA’s Center for Drug Evaluation .

The new drug is available under the brand name Vyleesi, it is also known as Bremelanotide, or “Barbie’s medicine.” It is a synthetic hormone that activates key brain receptors that are involved in sexual reactions. The drug reduces “inhibition” and increases nervous excitement.

Vyleesi is administered by injection using a pen device. Women can use “female Viagra” on their own in the periods preceding menopause with reduced sex drive.

At a new drug manufacturer, AMAG Pharmaceuticals Inc. , recommend injecting 45 minutes before the “expected proximity”.

Meanwhile, the FDA recognizes that the mechanism of action of Vyleesi in the brain is still not known. Therefore, women are advised not to take more than one dose within 24 hours – or not to take more than eight injections per month.

However, reduced sexual desire can be a signal of negative psychological processes, including stress that needs to be treated, and not dull its symptoms with medication. In this regard, some experts insist that additional research is needed by Vyleesi , and the FDA, they said, did not even convene an advisory group before giving the green light to drug sales.

In 2015, the U.S. Food and Drug Administration has already approved the production of another drug that boosts sexual desire in women, flibanserin. Then clinical trials also did not prove its effect.