FDA Considering Drug Designed to Improve Sexual Desire

Bremelanotide is an on-demand therapy for women with hypoactive sexual desire disorder.

Hypoactive sexual desire disorder (HSDD) is defined as a distressing loss of interest in sex. There is currently one drug on the market for HSDD that was approved by the U.S. Food and Drug Administration (FDA) in 2015: Addyi (fibanserin), from Sprout Therapeutics. The approval of this drug led to significant debate over whether sexual desire is a medical condition that should be treated with a drug. Ultimately, the drug had minimal sales causing the issue to become less relevant.

 

That debate is being renewed, however, as the FDA considers whether to approve a second treatment for HSDD. The drug is bremelanotide from AMAG Pharmaceuticals. AMAG says that their drug is as effective as Addyi but with reduced side effects. Addyi is an oral treatment, while bremelanotide is an injection that patients self-administer on demand. Addyi also cannot be taken after drinking alcohol, a restriction that AMAG’s drug would not have.


The main argument against approval is that sexual desire is a highly complex, natural function that is affected by environmental factors. By prescribing drugs for a lack of desire, it is possible to pathologize normal human functions.

 

Others argue that the distress that women suffer from HSDD feel is real and can impact not only their relationships but all aspects of life. Helping reduce that distress can, therefore, have profound effects.

 

Bremelanotide targets an excitatory receptor called melanocortin 4, helping overcome inhibition, improving desire and reducing distress. In two clinical trials involving over 1,200 women, the drug was shown to decrease at the median distress by one point from baseline on a four-point scale.

 

One challenge if the drug is approved will be finding women who can take it. To be diagnosed with HSDD, a woman must seek help for loss of desire such that she finds distressing, and her doctor must rule out all other possible causes—from the individual relationship to the affects of other medicines or surgeries. It is estimated that approximately 5 million women in the United States could be candidates for bremelanotide, but it is unknown what percentage would actually seek treatment.

Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.