Flibanserin: First Global Approval.

Article Details

Citation

Copy to clipboard

Deeks ED

Flibanserin: First Global Approval.

Drugs. 2015 Oct;75(15):1815-22. doi: 10.1007/s40265-015-0474-y.

PubMed ID

26412054 [ View in PubMed

]

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.

DrugBank Data that Cites this Article

Drugs

Flibanserin

Drug Targets

Drug	Target	Kind	Organism	Pharmacological Action	Actions
Flibanserin	5-hydroxytryptamine receptor 1A	Protein	Humans	Yes	Agonist	Details
Flibanserin	5-hydroxytryptamine receptor 2A	Protein	Humans	Yes	Antagonist	Details
Flibanserin	Dopamine D4 receptor	Protein	Humans	Yes	Antagonist Agonist	Details

Drug Enzymes

Drug	Enzyme	Kind	Organism	Pharmacological Action	Actions
Flibanserin	Cytochrome P450 3A4	Protein	Humans	No	Substrate	Details