UPDATE: FDA panel recommends women's libido drug despite safety concerns
UPDATE: On Thursday, an FDA advisory committee recommended approval of Sprout Pharmaceuticals' women's libido drug flibanserin, which will be marketed as Addyi if ultimately approved by the FDA.
The recommendation came as a bit of a surprise considering the drug has already been twice-rejected by the FDA. Even earlier this week, the agency expressed concerns about its side effects, including fainting and accidental injury.
But it appears that continued pressure over a lack of women's libido medications, in addition to Sprout's campaign to prove to the agency that the drug is safe and medically necessary for many women, is starting to sway agency officials. Flibanserin has been dubbed as "women's Viagra," although that is not exactly an apt description, given that it is aimed at treating a very specific population of women whose lack of sexual desire causes distress.
- Flibanserin, which is made by privately held Sprout Pharmaceuticals, was designed for treatment of premenopausal women whose lack of sexual desire causes distress.
- As the FDA prepares for a formal external review of flibanserin, concerns about fainting and accidental injury are emerging (Updated above).
- Preliminary FDA review found that flibanserin, which will have the trade name Addyi if approved, statistically improves the number of sexually satisfying events (SSEs) a women has when taking the drug.
For the FDA, this is a classic scenario of asking whether the risks outweigh the benefits. There are benefits associated with flibanserin, but they are not the kind of benefits that knock your socks off. Overall, women who took flibanserin experienced increased SSEs, as well as a reduction in distress related to low sexual desire.
But although flibanserin increases overall monthly sexual satisfaction, it does not increase daily satisfaction. And upon closer inspection, in clinical trials, flibanserin increased the average number of SSEs per month by 0.5 to 1, from a baseline of 2 to 3.
On the risk side, flibanserin, an SSRI originally developed to treat depression (but never approved) increases the risk of fainting, especially when consumed with alcohol. This may be one reason that the FDA has rejected this drug twice.
The third time may yet be the charm. There is intense pressure from women's groups, which claim that female sexual dysfunction is not properly addressed, especially compared with the numerous treatment options available for men with sexual dysfunction.