Flibanserin: First Global Approval
- 28 September 2015
- journal article
- review article
- Published by Springer Science and Business Media LLC in Drugs
- Vol. 75 (15), 1815-1822
- https://doi.org/10.1007/s40265-015-0474-y
Abstract
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.Keywords
This publication has 21 references indexed in Scilit:
- Open-Label Extension Study of Flibanserin in Women with Hypoactive Sexual Desire DisorderThe Journal of Sexual Medicine, 2012
- Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the VIOLET StudyThe Journal of Sexual Medicine, 2012
- Flibanserin and 8‐OH‐DPAT Implicate Serotonin in Association between Female Marmoset Monkey Sexual Behavior and Changes in Pair‐Bond QualityThe Journal of Sexual Medicine, 2012
- Treatment of Hypoactive Sexual Desire Disorder in Premenopausal Women: Efficacy of Flibanserin in the DAISY StudyThe Journal of Sexual Medicine, 2012
- Continued Efficacy and Safety of Flibanserin in Premenopausal Women with Hypoactive Sexual Desire Disorder (HSDD): Results from a Randomized Withdrawal TrialThe Journal of Sexual Medicine, 2011
- Flibanserin: Initial Evidence of Efficacy on Sexual Dysfunction, in Patients with Major Depressive DisorderThe Journal of Sexual Medicine, 2010
- ORIGINAL RESEARCH—BASIC SCIENCE: Acute and Repeated Flibanserin Administration in Female Rats Modulates Monoamines Differentially Across Brain Areas: A Microdialysis StudyThe Journal of Sexual Medicine, 2010
- Flibanserin, a potential antidepressant drug, lowers 5‐HT and raises dopamine and noradrenaline in the rat prefrontal cortex dialysate: role of 5‐HT1A receptorsBritish Journal of Pharmacology, 2003
- Electrophysiological examination of the effects of sustained flibanserin administration on serotonin receptors in rat brainBritish Journal of Pharmacology, 1999
- BIMT 17, a 5-HT2A receptor antagonist and 5-HT1A receptor full agonist in rat cerebral cortexNaunyn-Schmiedebergs Archiv für experimentelle Pathologie und Pharmakologie, 1995