This month, Flibanserin, commonly referred to as “female Viagra,” goes to the full Food and Drug Administration for a vote of approval. In early June, a federal advisory committee to the FDA recommended approval. The final vote is due on or before August 18.
The entire concept of Female Sexual Dysfunction (FSD) is controversial. Does the FDA exhibit gender bias by approving drugs for male sexual dysfunction that have potentially serious side effects while not approving any drug for FSD? Is FSD real? Is the female sexual response simply too complicated to be addressed by medication?
The FDA has rejected both Intrinsa, a female testosterone patch that was approved in Europe and Australia, as well as Flibanserin in its first submissionseveral years ago. The current submission includes additional safety data requested by the FDA.
Dr. Robin Kroll and Dr. Suzanne Barbier (now retired) have been pioneers in the field of female sexual dysfunction research. Over the last 15 years they have conducted clinical trials on Viagra, Intrinsa, Testim, Flibanserin, Vaginorm, Bremelanotide, and several other compounds. This work has made it clear to us that there is a pressing need for acknowledgment of the impact of FSD on the lives of women and for treatment options to be made available.
Should Flibanserin be approved, we look forward to introducing it to the Pacific Northwest. With many years experience diagnosing and treating FSD, we look forward to a new treatment option. Our experience with Flibanserin has been extensive and we hope to have the opportunity to use it outside of the clinical trial setting.
For now, we can only wait patiently, as women have for years and years, to see what the FDA will decide.