FDA Approval of Bremelanotide for Female Sexual Desire Disorder Changes Market

JUNE 24, 2019
Kevin Kunzmann
FDAThe new approval for bremelanotide injection (Vyleesi) serves as an unprecedented embrace to US marketing for female sexual dysfunction therapy.

Last week, the US Food and Drug Administration (FDA) approved bremelanotide as the first product indicated for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). The melanocortin receptor agonist, from Palatin Technologies, will be marketed as a self-injecting, subcutaneous pen to be used in anticipation of patients’ sexual encounters.

HSDD is currently the most common form of sexual dysfunction among women in the US. It’s characterized by reduced sexual desire and distress not attributed to any other medical, pharmacologic, psychiatric, or even relationship-based issues.

When the therapy reaches the market—as anticipated, in September of this year—it will be available for a patient population which market research indicates up to 95% of all afflicted premenopausal women are unaware of. According to Palatin, approximately  6 million women meet the diagnostic criteria for generalized HSDD.

In an interview with MD Magazine® earlier this year, Maria Sophocles, MD, medical director of Women’s Healthcare of Princeton, called female sexual dysfunction a “woefully underserved” facet of care in biopharmacy. She likened the limited availability of therapeutic options for women with sexual disorders to the androgenic model of sexuality—which dictates that male sexual pleasure is prioritized over females’.



“This is reflected in the biopharmaceutical industry, if you look at Viagra and its overwhelming success and the numerous other drugs for male erection that have been marketed successfully,” Sophocles said at the time. “There is only one FDA approved medication that relates to or whose purpose is to enhance the female sexual experience.”

Sophocles noted that common sexual dysfunction symptoms in women include physical manifestations—painful intercourse, pelvic pain,  endometriosis, muscle dysfunction—as much as they include psychiatric issues—depression, lowered self-esteemed, and burdens on relationships.

She agreed with the notion that sexual dysfunction has been perceived as a taboo topic among most afflicted women. She estimated more than 80% of her patients do not address dysfunctions at their visits; that rate is returned by an equal 80-plus percent of physicians who fail to ask about it.

“So there is a little bit of a, ‘Don't ask, don't tell’ problem,” Sophocles said. “Women are, to use a cliched term, suffering in silence. They're not talking about it, they often feel it's just them, there's something wrong with them, they're broken.”

The current mechanism of action executed by bremelanotide is unknown, but investigators believe the therapy functions by binding to the central nervous system’s melanocortin receptors—a region associated with sexual function.

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