Literature DB >> 26412054

Flibanserin: First Global Approval.

Emma D Deeks1.   

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.

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Year:  2015        PMID： 26412054     DOI： 10.1007/s40265-015-0474-y

Source DB:  PubMed          Journal:  Drugs        ISSN： 0012-6667            Impact factor:   9.546


  20 in total

1.  Flibanserin and 8-OH-DPAT implicate serotonin in association between female marmoset monkey sexual behavior and changes in pair-bond quality.

Authors:  Yves Aubert; Morgan L Gustison; Lindsey A Gardner; Michael A Bohl; Jason R Lange; Kelly A Allers; Bernd Sommer; Nicole A Datson; David H Abbott
Journal:  J Sex Med       Date:  2012-02-03       Impact factor: 3.802

2.  Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the VIOLET Study.

Authors:  Leonard R Derogatis; Lawrence Komer; Molly Katz; Michèle Moreau; Toshio Kimura; Miguel Garcia; Glen Wunderlich; Robert Pyke
Journal:  J Sex Med       Date:  2012-01-16       Impact factor: 3.802

3.  Open-label extension study of flibanserin in women with hypoactive sexual desire disorder.

Authors:  Christopher Jayne; James A Simon; Leslie V Taylor; Toshio Kimura; Lynna M Lesko
Journal:  J Sex Med       Date:  2012-10-11       Impact factor: 3.802

4.  Electrophysiological examination of the effects of sustained flibanserin administration on serotonin receptors in rat brain.

Authors:  L E Rueter; P Blier
Journal:  Br J Pharmacol       Date:  1999-02       Impact factor: 8.739

5.  Treatment of hypoactive sexual desire disorder in premenopausal women: efficacy of flibanserin in the DAISY study.

Authors:  John Thorp; James Simon; Dan Dattani; Leslie Taylor; Toshio Kimura; Miguel Garcia; Lynna Lesko; Robert Pyke
Journal:  J Sex Med       Date:  2012-01-12       Impact factor: 3.802

6.  Developing treatments for female sexual dysfunction.

Authors:  R Jordan; T J Hallam; P Molinoff; C Spana
Journal:  Clin Pharmacol Ther       Date:  2010-11-17       Impact factor: 6.875

7.  Efficacy and safety of flibanserin in postmenopausal women with hypoactive sexual desire disorder: results of the SNOWDROP trial.

Authors:  James A Simon; Sheryl A Kingsberg; Brad Shumel; Vladimir Hanes; Miguel Garcia; Michael Sand
Journal:  Menopause       Date:  2014-06       Impact factor: 2.953

8.  Region-dependent effects of flibanserin and buspirone on adenylyl cyclase activity in the human brain.

Authors:  Donatella Marazziti; Lionella Palego; Annalisa Giromella; Maria Rosa Mazzoni; Franco Borsini; Norbert Mayer; Antonio Giuseppe Naccarato; Antonio Lucacchini; Giovanni Battista Cassano
Journal:  Int J Neuropsychopharmacol       Date:  2002-06       Impact factor: 5.176

9.  BIMT 17, a 5-HT2A receptor antagonist and 5-HT1A receptor full agonist in rat cerebral cortex.

Authors:  F Borsini; E Giraldo; E Monferini; G Antonini; M Parenti; G Bietti; A Donetti
Journal:  Naunyn Schmiedebergs Arch Pharmacol       Date:  1995-09       Impact factor: 3.000

10.  BIMT 17, a 5-HT1A receptor agonist/5-HT2A receptor antagonist, directly activates postsynaptic 5-HT inhibitory responses in the rat cerebral cortex.

Authors:  F Borsini; A Ceci; G Bietti; A Donetti
Journal:  Naunyn Schmiedebergs Arch Pharmacol       Date:  1995-09       Impact factor: 3.000
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  5 in total

Review 1.  Flibanserin for hypoactive sexual desire disorder: place in therapy.

Authors:  Faina Gelman; Jessica Atrio
Journal:  Ther Adv Chronic Dis       Date:  2017-01-18       Impact factor: 5.091

2.  Preclinical Abuse Potential Assessment of Flibanserin: Effects on Intracranial Self-Stimulation in Female and Male Rats.

Authors:  Matthew F Lazenka; Bruce E Blough; S Stevens Negus
Journal:  J Sex Med       Date:  2016-01-28       Impact factor: 3.802

Review 3.  Balance of the Sexes: Addressing Sex Differences in Preclinical Research.

Authors:  Yasmin Zakiniaeiz; Kelly P Cosgrove; Marc N Potenza; Carolyn M Mazure
Journal:  Yale J Biol Med       Date:  2016-06-27

4.  Retinal Neuroprotective Effects of Flibanserin, an FDA-Approved Dual Serotonin Receptor Agonist-Antagonist.

Authors:  Aaron S Coyner; Renee C Ryals; Cristy A Ku; Cody M Fischer; Rachel C Patel; Shreya Datta; Paul Yang; Yuquan Wen; René Hen; Mark E Pennesi
Journal:  PLoS One       Date:  2016-07-22       Impact factor: 3.240

5.  Development and Greenness Evaluation of Spectrofluorometric Methods for Flibanserin Determination in Dosage Form and Human Urine Samples.

Authors:  Rasha Ahmed; Inas Abdallah
Journal:  Molecules       Date:  2020-10-25       Impact factor: 4.411
  5 in total

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