Thursday, July 2, 2015

A Libido Pill for Women?

Move over, Viagra and Cialis. Women are about to get a sexual satisfaction pill of their own. The only thing is, does it work?

Flibanserin is not a hormone-type drug; it is a neuromodulator that alters certain neurotransmitter pathways in the brain. Specifically, it is a 5-hydroxytryptamine receptor agonist/antagonist. The FDA twice rejected the manufacturer's application for approval, but now seems poised to approve it to treat two little known disorders in women; hypoactive sexual desire disorder (HSDD) and female sexual interest/arousal disorder (FSIAD).

Supposedly, Flibanserin affects a woman's sense of pleasure during sex, but a close reading of the FDA report on effectiveness is not very encouraging. In the study, half of the women received Flibanserin and the other half received a placebo. Women receiving Flibanserin reported just 0.5 to 1 more "satisfying sexual events" per month than the placebo group, from a baseline of 2-3 per month. Will that be enough for women to want to use this pill?

If Flibanserin is approved, the marketing campaign will probably focus on convincing women and their doctors that HSDD and FSIAD are far more prevalent than we think. At least, that has been the pattern with Viagra and Cialis for the treatment of erectile dysfunction (ED) in men. The latest pitch I heard is that half of all men over 40 suffer from some symptoms of ED. That sounds like a stretch....

You can read the entire 136-page FDA briefing document on Flibanserin here.

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