Flibanserin: First Global Approval

Flibanserin (Addyi™) is chemically described as a benzimidazole and is being developed by Sprout Pharmaceuticals for the treatment of hypoactive sexual desire disorder (HSDD). The drug has a high affinity for serotonin 5-HT1A and 5-HT2A receptors (5-HT1A agonist/5-HT2A antagonist) and is believed to treat HSDD by increasing levels of dopamine and noradrenaline and lowering levels of serotonin in the brain. Flibanserin has been approved in the USA for the treatment of premenopausal women with acquired, generalized HSDD. Earlier phase III development of the agent for HSDD in the EU and Canada had been discontinued by Boehringer Ingelheim, following regulatory feedback. Boehringer Ingelheim had also evaluated flibanserin for the treatment of depression but, due to displaying very mild antidepressant activity, its development in this indication was discontinued. This article summarizes the milestones in the development of flibanserin leading to its first approval for HSDD.