FDA Takes Significant Step for Women’s Sexual Health

By Karen E. Boyle, M.D., F.A.C.S.

As a physician specializing female sexual disorders, I was very encouraged when the FDA Advisory Committee finally recommended approval of flibanserin for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. 

After years of public hearings and debate, the FDA’s Advisory Committee made the right choice.  The science is clear on flibanserin.  It has been tested in more than 11,000 women – making it one of the most studied women’s health products in history; its safety is well characterized, as the most common side effects include dizziness, sleepiness and nausea; and the women in the trials themselves said the effects were “meaningful” using the scientific tool that the FDA required. 

Many of my patients are surprised that no medical treatment options are available for this disorder, which impacts 1-in-10 women in the United States. Physicians like me who regularly treat men, however, have a plethora of options available to offer our male patients, whereas for my female patients, all of my recommendations have to be off-label, non-FDA approved treatments. Women have ZERO medical treatment options for their condition, while at the same time men enjoy 26 options marketed for their own sexual dysfunction.

The notion that there is not a patient population desperately in need of flibanserin is simply ridiculous. I personally see hundreds of women a year, young women, women who have struggled with issues of diminished sexual desire for years, who would greatly benefit from flibanserin.

These women, appropriately diagnosed with HSDD by physicians, often struggle with intimacy, happiness and self-fulfillment. They have relationship difficulties, marital discord and general dissatisfaction from their diminished interest in intercourse. You know these women – they could be your co-worker, your neighbor, your sister or even your partner.  Women with HSDD desire to have their disease process acknowledged and confronted, with a solution that could offer them statistically significant improvement in the number of intimate experiences they enjoy a month. 

The HSDD population and the female sexual dysfunction population of patients at large struggle for their voices to be recognized. With no medical treatment to offer, physicians shy away from inquiring to women about their struggles with intimacy and sexual desire, orgasm and sexual satisfaction. These women often feel that they are living in a misogynistic society, with an overt double standard with regard to their sexual function as compared to their male counterparts.

Simply put, women need a safe, FDA-approved medication to treat hypoactive sexual desire disorder. The danger in the non-regulated supplement world is dramatic. In the absence of approved treatments, women turn to expensive internet-purchased products that promise invalidated results. Unregulated products can be dangerous. Women are putting animal steroid into their systems unknowingly; they are borrowing their partners’ medications hoping that they will have similar results; they are desperate for a treatment for their diminished sexual desire, and it’s important enough to them to risk their health and safety. 

As a physician and surgeon, my commitment is to provide superior care for my patients, and to keep them healthy. For my sexual dysfunction patients, I do not feel that I can do my job effectively without help from the FDA.  Women with HSDD deserve the safety and peace of mind that comes with access to FDA-approved medical treatment options. 

I applaud the FDA’s recognition of female sexual dysfunction as a key unmet medical need and urge the FDA to make history in August by issuing final approval of the first-ever medical treatment option for women’s most common sexual complaint. The FDA will be doing more than just approving a drug if flibanserin becomes a prescribed medication. In fact, the FDA will be making a global statement that women’s sexual health and women’s intimacy matters and deserves attention.


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