Just ahead of a June 18 FDA panel review, the FDA has released a staff review of Boehringer Ingelheim's sexual desire drug flibanserin, saying it may not be either safe or effective.
Unlike male sex drugs, which are designed to stimulate the penis, Boehringer's therapy is aimed at the brain. The agency staffers concluded that the drug "failed to demonstrate a statistically significant improvement" and was linked to a range of side effects including appendicitis, depression, dizziness and loss of consciousness. But they also noted the therapy was linked to somewhat more satisfying sexual encounters.
"This points to the brain as the important organ in desire, as central to the feminine experience of sexuality," lead investigator John Thorp tells Bloomberg. "This is a radical change."
Male libido pills have created a multibillion-dollar market. And developers like Boehringer and BioSante believe the female libido market could one day rival that. In order to get close, Boehringer will have to overcome a high level of skepticism outlined in the FDA staff review.