Bremelanotide and flibanserin for low sexual desire in women: the fallacy of regulatory precedent.

The US Food and Drug Administration (FDA) has approved two drugs for 'hypoactive sexual desire disorder' in women, flibanserin (Addyi) in 2015 and bremelanotide (Vyleesi) in 2019. In this paper we examine the outcome measures and clinical trial data upon which regulatory approval was based. In clinical trials, flibanserin led to an average of only one additional enjoyable sexual experience every two months, bremelanotide to none.

Apples and Oranges: "Sexual Medicine" and the Effort to Deny That Counting and Classifying Are Political Acts.

Criticisms and controversies about scientific method are rarely just about science. As or more often, they are sociological exercises in boundary patrol, helping determine which work is in and which is out. The recent back-and-forth on the question of whether psychological treatments for sexual desire complaints are sufficiently "rigorous" is part of the effort to define the field of sexual medicine.