Women May Have an FDA-Approved Drug to Treat the Most Common Sexual Dysfunction

That's been my credo over 40+ years of fighting for gender equity. And trust me, I've been outraged for nearly every minute of the past four decades. With all the basic rights women have had to fight tooth and nail to win and hang on to over that tumultuous period, how could I not?

Next week, however, we are on track to make the kind of progress in gender equity that usually comes once in a generation. This will be a step forward that makes the battles that came before worth it and, on a personal note, serves as a soothing salve to my chronic outrage. Next week, the FDA will issue its final decision on approval of flibanserin, the first-ever medical treatment for women's most common sexual dysfunction, Hypoactive Sexual Desire Disorder. HSDD is a chronic and complete lack of libido marked by distress, which has devastating impacts on women's relationships, identities and daily lives. We have never been closer to such a huge victory for women; yet just last year, it seemed nearly impossible.

In January of 2014, my outrage was as white-hot as ever. The FDA had just rejected flibanserin, the first drug to address HSDD, even though extensive clinical trials demonstrated it was quite safe and effective. At almost the same time, the FDA approved--wait for it--the 24th drug for men's sexual dysfunction. For me and for so many other women's health and rights advocates, this was unacceptable. So a group of us embarked upon the "Have Outrage, Will Travel Tour." Along with leaders of five other major women's organizations and a leading researcher and doctor in the field, l loaded onto a bus and we set course for FDA headquarters to voice our concerns about this latest setback in women's sexual health.

After that most unsatisfactory meeting, we sounded the alarm and invited women to participate in a conversation that has been taboo for far too long. Until women had a place to speak up, nothing would change. Science would continue to be ignored. We formed Even the Score, a campaign for gender equity in sexual health. Our mission: to serve as a voice for American women who believe it's time to level the playing field when it comes to the treatment of women's sexual dysfunction.

Fast forward over a year and a half. Next week the FDA has the opportunity to make a huge course correction in the way we tell women how much we value their sexual health. Not only do we have patients, advocates and fairness on our side, we also have doctors, experts and the cold, hard data. With clinical trials on over 11,000 women, flibanserin is now the most widely tested drug for women in pharmaceutical history. And the data is clear: it is safe and effective. Overall, women on the drug reported, with statistical significance, increases in sexual desire and decreases in distress with the most common side effects being nausea, dizziness and sleepiness.

To put that safety profile in perspective, let's take a look at sexual dysfunction medications currently available to men. A man struggling with erectile dysfunction has access to a wide range of treatment options--as well he should. However, he must first weigh the risks and benefits of those treatments with his doctor. If he thinks Cialis could work best, he must accept the risk of seizures, chest pain, swelling of hands and feet, and memory problems. If Viagra seems like a better option, he must prepare for the possibility of sudden vision or hearing loss, irregular heartbeat and painful erections lasting four hours or longer.

All this isn't to scare men away from treating a serious and truly life-impacting medical condition, but to highlight the risk/benefit analysis that the FDA has said it trusts men and their doctors to make. In approving flibanserin, the FDA will finally tell women that it trusts HSDD patients to weigh the risk of side effects with their doctors and discontinue treatment if they don't respond to it or if side effects become unmanageable. That's the exact same trust they've afforded to men for so long.

As the chair of the Even the Score coalition, I do not advocate for one particular drug; I advocate for safe and effective treatment options for female sexual dysfunction. Flibanserin will not work for every single patient. What drug does? But once we open this door, we open the pipeline for further research and drug development to provide women just as many treatment options for their sexual dysfunction as men have.

FDA's approval of this drug would not only give hope to the 16 million American women who struggle, often silently, with HSDD, but also to every other American woman. It sends a clear and resounding signal that we, as a society, value women's sexual health and satisfaction just as much as we do men's. This would be just the latest step towards the gender equality for which I and countless others have fought so hard and traveled so far.

"Have Outrage, Will Travel!"