FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women


WASHINGTON-U.S. women will soon have another drug option created to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours.

The approval from the Food and Drug Administration adds another drug - the other is a daily pill that received FDA clearance in 2015 - meant to raise women's sexual desires. In that way, she added, it is similar to depression, which has biological underpinnings that have been revealed over decades, prompting the development of drug therapies.

The drug's developer, Amag Pharmaceuticals, could also face some of the same hurdles that have plagued the lone pill previously approved for the condition, including unpleasant side effects and limited insurance coverage.

The new drug, called Vyleesi, was approved by the US Federal Drug Administration on Friday. Side effects include nausea, vomiting, injection site reaction and headaches.

AMAG licensed Vyleesi from Palatin Technologies Inc. and under the terms of their agreement the FDA approval triggers a $60 million payment to Palatin, plus tiered royalties tied to sales milestones.

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship or the effects of a medication or other drug substance.

Still, the pharmaceutical industry has long pointed to surveys-some funded by drugmakers-suggesting that it is the most common female sexual disorder in the nation, affecting roughly 1 in 10 women.

And there was one other caveat: Vyleesi can hike blood pressure, so people with heart disease or high blood pressure should not take it, the FDA said. The approval was based on women's responses to questionnaires that showed increases in sexual desires and decreases related to stress.

The disorder is a condition in which women lose interest in sex. About 40% of patients in clinical trials experienced nausea. Around 20 percent of women dropped out early, Bloomberg reported.

Vyleesi acts on receptors for a brain-stimulating hormone called melanocortin, which is associated with sexual arousal and appetite in both men and women.

Critics have pointed out that almost 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.

Many accused the agency of being sexist when it first rejected the drug in 2013.

Most insurers refused to cover the drug, citing lackluster effectiveness, and many women balked at the $800-per-month price. Women balked at the $800 monthly costs past year, which was lowered to $400.

Cynthia Pearson, executive director of the National Women's Health Network, said the group was "disappointed" by the approval and said that women "simply do not have enough information to make an informed decision about whether the drug is safe and effective".