Well, they finally did it! The FDA has approved the first Pharmacologic treatment for women who suffer with hypoactive sexual desire disorder (HSDD). As a long time member of ISSWSH, I have been following the development of this story closely, and was thrilled when I received the following news . . .
|It is with tremendous excitement that we share the announcement that flibanserin, a drug for acquired, generalized hypoactive sexual desire disorder (HSDD) developed by Sprout Pharmaceuticals, was approved by the FDA on August 18, 2015. This follows the June 4, 2015 meeting of their Advisory Committee whose members voted 18-6 for approval.
This historic event marks the availability of the first pharmacologic treatment for women suffering from HSDD. We applaud the FDA for recognizing female sexual disorders as one of their top 20 conditions for which there is unmet medical need and for making their decision to approve flibanserin based on science. We are optimistic that this approval will stimulate more research and drug development for HSDD and other female sexual disorders for which therapeutic options are greatly needed.
We also extend robust gratitude to many of our leaders and members who played a critical role in this long awaited advancement in women’s health care. By serving on the FDA Advisory Panel, speaking for the sponsor at the FDA, testifying at the Open Public Hearings, and caring for patients who suffer from sexual disorders without approved medical treatment options, ISSWSH members provided broad expertise, invested countless hours, and contributed in many ways to this monumental leap forward in sexual medicine.
Flibanserin will be marketed with the trade name Addyi. As a multidisciplinary, scientific organization dedicated to research, clinical practice, and education, ISSWSH is poised to develop and disseminate clinical practice guidelines regarding screening, diagnosis, and management strategies for HSDD. Through our robust educational infrastructure, we will help to ensure appropriate, safe, and selective treatment of HSDD with Addyi, now that approval has finally arrived!
According to one survey, about 10 percent of women suffer from hypoactive sexual desire disorder. The F.D.A. said the drug was approved for women whose loss of sexual desire causes marked distress or interpersonal difficulty and is not the result of illness, relationship problems or side effects of other medicines.
Dr. Lauren Streicher, associate professor of clinical obstetrics and gynecology at Northwestern University, said she sensed great interest for a drug like Addyi among her patients. She said the drug’s availability would encourage many women to talk to doctors about their sexual problems for the first time.
As a women’s health specialist, I am a huge advocate of educating women and encouraging conversation on those hard-to-talk-about topics such as sexual dysfunction. The approval of Flibanserin is going to change the conversations women have with their doctors in much the same way that Viagra has opened up the conversations men have with their doctors.
The approval of Flibanserin is much more than just a medical option for the 16 million American women dealing with HSDD, it is also a huge step forward in the way society views women’s sexual health.
Even if you are not personally affected by HSDD, please join the conversation in saying #ThankYouFDA and sharing this video:
Sources: ACOG, NYTimes, Even The Score