Flibanserin recommended for approval by the FDA Advisory Committee Panel
- Created: Friday, 05 June 2015
Dear ISSWSH members,
It is with great excitement that I share the announcement that flibanserin, a drug for hypoactive sexual desire disorder (HSDD) developed by Sprout Pharmaceuticals, was recommended for approval by the FDA Advisory Committee Panel on June 4, 2015.
This event opens the door for the first treatment for women suffering from HSDD, but more importantly sends the message that the FDA is now willing to entertain new drug applications from other companies. We are optimistic that this occurrence will instigate more research and eventually other therapeutic options. We also offer deep gratitude to many of our members who played a key role in this decision by voting as members of the FDA Advisory Panel, speaking as presenters on behalf of the sponsor, providing testimony during the Open Public Hearing, and caring for patients who also spoke at the Hearing.
As a multidisciplinary, scientific organization dedicated to research, clinical practice, and education, we are poised to develop and disseminate clinical practice guidelines regarding screening, diagnosis, and management strategies. Through our robust infrastructure of educational programs, we will ensure appropriate, safe, and selective treatment of HSDD with flibanserin when final approval comes.
Sharon J. Parish, MD, IF
ISSWSH President, 2014-2016