A new 'female Viagra' approved by FDA despite skepticism

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The Food and Drug Administration on Friday approved sales of a new drug intended to enhance sexual desire in women.

 

 

Marketed as Vyleesi, also known as bremelanotide, the medication is a shot that comes in a push pen device that can be self-administered as needed for premenopausal women who experience marked distress as a result of low sexual desire, reports The Washington Post.

 

"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 Hylton Joffe, director of the FDA Center for Drug Evaluation and Research's Division of Bone, Reproductive and Urologic Products. "Today's approval provides women with another treatment option for this condition. As part of the FDA's commitment to protect and advance the health of women, we'll continue to support the development of safe and effective treatments for female sexual dysfunction."

 

Julie Krop, chief medical officer for AMAG Pharmaceuticals Inc., which makes the drug, recommends using it about 45 minutes before the "anticipation" of intimacy. She said the drug is a synthetic hormone that activates key brain receptors involved in sexual responses by reducing inhibition and increasing what's known as neural excitation.

 

"It's not just about low sexual desire, but about how it impacts patients' relationships and quality of life," Krop said in an interview. "These women are really suffering."

The drug is intended to be a treatment for hypoactive sexual desire disorder, or HSDD, which the medical community recognises can be a serious issue. The FDA acknowledged that it's not clear how the drug works.

 

And there's disagreement about whether drugs are the right approach - low sexual desire can be a result of numerous psychological, physiological or external factors including stress - and how widespread the condition really is.

 

Vyleesi activates certain receptors, but the mechanism by which it improves sexual desire and related distress is unknown. Patients inject Vyleesi under the skin of the abdomen or thigh at least 45 minutes before anticipated sexual activity. Patients should not use more than one dose within 24 hours or more than eight doses per month.

 

One study estimated that as many as 1 out of 10 women may have low sexual desire, and the FDA several years ago convened a meeting to better understand the impact of female sexual dysfunction.

 

Critics have pointed out that nearly all of the doctors on the recent panel that defined HSDD were consultants or advisory board members for Sprout Pharmaceuticals, the drugmaker that introduced the world to the first women's libido drug, Addyi, also known as flibanserin, in 2015.

 

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