Thank You FDA

“I’ve tried EVERYTHING.”

“I don’t know what else I can do.”

“This has already had a huge impact on my marriage.”

I hear phrases like these all too often. By the time a patient has made it to my office to talk to me about her distressing lack of sexual desire, she has often struggled silently for years. She’s tried herbal remedies. She’s tried sex toys. She’s tried a plethora of snake oil treatments from God-knows-where. She’s tried everything imaginable to get regain her libido, but nothing has worked.

In most cases, that’s because she has Hypoactive Sexual Desire disorder (HSDD), a condition defined as a chronically low or nonexistent libido, stemming from a neurotransmitter imbalance, and marked by distress. It is the most common form of female sexual dysfunction and its effects can be devastating.

I’ve had women in my office who are heartbroken, sobbing about how much of a toll their lack of sexual desire has taken on their life. They describe in devastating detail the impact of this condition on their marriages, their families, their self-esteem and their very identities. And while I know the exact biological mechanism that is causing it, I have had nothing to offer them besides a shoulder to cry on. That is, until now.

Yesterday, the FDA approved flibanserin (also known as Addyi), the first-ever medical treatment for HSDD. Flibanserin is a once-daily, non-hormonal pill that is taken at bedtime and works on three key chemicals in the brain involved in the sexual desire response, restoring balance to excitatory and inhibitory factors for women with HSDD.

With this approval, the FDA has said it trusts health care providers like me to educate, counsel and provide informed consent regarding both the benefits and the risk of side effects for this treatment to my female patients, just as it has said it trusts health care providers to do the same with their male patients. If health care providers can inform male patients on the risk of side effects of the 26 different treatment options available to them for their sexual dysfunctions, we can certainly do the same with our female patients who may benefit from this first FDA-approved treatment option.

Let’s be clear, the science behind the drug is strong and undeniable. Flibanserin has been studied in clinical trials of more than 11,000 women and has shown statistically significant effects over placebo in the two key ways: increasing sexual desire and decreasing distress. Overall, these women experienced significant improvements at every point of measurement in the clinical trials and saw benefits as early as four weeks into treatment. And while this treatment option will not be right for every woman, it will certainly work for many of the estimated 16 million American women struggling with HSDD.

Without a doubt, the approval of flibanserin is a major advance for women’s sexual health. By being the first-in-class medical treatment, flibanserin is sure to spur development in this embarrassingly under-researched area of women’s health. As a practitioner who sees women with sexual dysfunctions every day, I look forward to the continued research and development of further treatment options for women suffering from any type of sexual dysfunction.

It’s difficult to overstate how groundbreaking this approval is for my female patients. Where there was once an empty toolbox, I now have a safe and effective, FDA-approved treatment to offer. Where there was once hopelessness and isolation, there is now a potential solution. On behalf of my patients, and the other 16 million American women suffering from HSDD, I say “Thank you, FDA,” for finally putting a treatment into the hands of health care professionals to help these women who so desperately need and deserve it.

Lisa Larkin is scientific co-chair of Even the Score, an advocacy coalition of more than two dozen women’s health, rights and research organizations. She is also the director of the University of Cincinnati Health Women’s Center and an Associate Professor and Director of the Division of Midlife Women’s Health and Primary Care in the Department of Obstetrics and Gynecology at the University of Cincinnati. To learn more about the work of Even the Score: www.EvenTheScore.org.