Dive Brief:
- Sprout Pharmaceuticals' flibanserin, for the treatment of female sexual desire (and dubbed as a potential "women's Viagra"), has already been rejected by the FDA twice. But Sprout Pharma is hoping that the third time's the charm.
- Flibanserin was initially developed by Boehringer Ingelheim and sold to Sprout, a start-up, in 2011.
- The FDA rejected flibanserin in 2010 and then again in 2013 on the grounds that the benefits did not outweigh the risks, with the main risk being sleepiness. In clinical trials, roughly 10% of women reported sleepiness.
Dive Insight:
The back story for flibanserin harkens back to a discussion that has been taking place since the late 1990s, when Pfizer introduced Viagra (sildenafil) for men. Since then, a vocal group has seen the availability of a female sexual enhancer as the holy grail of pharmaceutical R&D for female consumer health.
In fact, a recent online petition to the FDA demanding "equal treament when it comes to sex" has almost 25,000 supporters, according to CBS News. Add to that Congressional support in the form of a four-person team headed by DNC chair Rep. Debbie Wasserman-Schultz (D-FL) requesting that flibanserin be reconsidered by the FDA. The letter points out that, although there are 24 FDA-approved medical treatments for male sexual dysfunction, there are none for women.
Now the data: In a 24-week study study published in 2010 by the American College of Obstetrics and Gynecologists, flibanserin-treated women reported an 18% improvement in sexual desire. In a separate study, published in December 2013 in Menopause, 38% of flibanserin-treated women enjoyed improved sex lives. Yet, 30% also experienced side effects, including headache, nausea, dizziness, and sleepiness. Eight percent of women experienced such serious side effects that they stopped treatment.
If approved, the indication for flibanserin will most likely be for the treatment of pre-menopausal women with hypoactive sexual desire disorder.