Will public pressure drive the FDA to approve a so-so female libido drug?
- Three FDA advisory panel members have expressed concerns about Sprout Pharmaceuticals' female libido drug flibanserin, including the aggressive social media campaign behind the product.
- In five weeks, the FDA will have to make a decision regarding approval of flibanserin, which was developed for women with hypoactive sexual desire disorder (HSDD).
- Flibanersin has already been rejected twice by the FDA but was recently recommended for approval by the advisory panel.
There is a great deal of controversy and hope surrounding Sprout's female libido drug—which was orignally developed, and then abandoned, by Boehringer Ingelheim. According to FDA panel members Walid Gellad, Kathryn Flynn, and G. Caleb Alexander, clinical trial results from flibanserin studies were not impressive, and the improvements experienced by women were marginal at best. Moreover, they assert that the endpoints, including increased number of sexually satisfying events each month, were not robust or sufficiently rigorous. Plus there are concerns about drug-related side effects, including hypotension, fainting, and somnolenece.
But that's not to say the other side of the argument has no merit, especially considering the fact that there are 26 drugs available to treat male sexual dysfunction (though not to treat low sexual desire), and nothing for women. There is an umet need for treatments to enhance female sexual experience and the drug is safe overall—for many that's all that matters. The takeaway: Flibanserin advocates point out that even a marginal improvement for women who suffer from HSDD is therapeutically worthwhile.