Dear ISSWSH members,
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!
Most sincerely,
Sharon J. Parish, MD, IF, NCMP
ISSWSH President, 2014-2016
Sheryl A. Kingsberg, PhD, IF
Chair, ISSWSH Advocacy Committee