Evaluation of Flibanserin

Gellad, Walid F.; Flynn, Kathryn E.; Alexander, G. Caleb

doi:10.1001/jama.2015.8405

Cited by 32 publications

(12 citation statements)

References 3 publications

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“…These wide‐ranging findings suggest that caution must be taken when prescribing serotonergic drugs to pregnant or lactating women. For example, flibanserin is closely related to the 5HT 2A/2C antagonist used in this study, ketanserin, and has recently received controversial FDA‐approval for the treatment of sexual dysfunction in premenopausal women (Gellad et al, ; Joffe et al, ). In addition, the use of SSRIs during pregnancy has recently been linked to a higher risk of Autism Spectrum Disorder (ASD) in the offspring (Boukhris et al, ), a disorder with a profound sex difference in diagnosis (Centers for Disease Control and Prevention, ) and possibly etiology.…”

Section: Discussionmentioning

confidence: 99%

Serotonin promotes feminization of the sexually dimorphic nucleus of the preoptic area, but not the calbindin cell group

Madden

Paul

Pritchard

et al. 2016

Developmental Neurobiology

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Testosterone and its metabolites masculinize the brain during a critical perinatal window, including the relative volume of sexually dimorphic brain areas such as the sexually dimorphic nucleus of the preoptic area (SDN), which is larger in males than females. Serotonin (5HT) may mediate this hormone action, since 5HT given during the second week of life decreases (i.e., feminizes) SDN volume in males and testosterone-treated females. Although previous work indicates that the 5HT receptor is sufficient to induce feminization, it is unclear whether other serotonin receptors are required and which subpopulation(s) of SDN cells are specifically organized by 5HT. Therefore, we injected male and female Sprague-Dawley rat pups with saline, a nonselective 5HTR agonist, a 5HT agonist, or a 5HT antagonist over several timecourses in early life, and measured the Nissl-SDN as well as a calbindin+ subdivision of the SDN, the CALB-SDN. When examined on postnatal day 18 or early adulthood, the size of the Nissl-SDN was feminized in males treated with any of the serotonergic drugs, eliminating the typical sex difference. In contrast, the sex difference in CALB-SDN size was maintained regardless of serotoninergic drug treatment. This pattern suggests that although gonadal hormones shape the whole SDN, individual cellular phenotypes respond to different intermediary signals to become sexually dimorphic. Specifically, 5HT mediates sexual differentiation of non-calbindin population(s) within the SDN. The results also caution against using measurement of the CALB-SDN in isolation, as the absence of an effect on the CALB-SDN does not preclude an effect on the overall nucleus. © 2016 Wiley Periodicals, Inc. Develop Neurobiol 76: 1241-1253, 2016.

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Section: Discussionmentioning

confidence: 99%

Serotonin promotes feminization of the sexually dimorphic nucleus of the preoptic area, but not the calbindin cell group

Madden

Paul

Pritchard

et al. 2016

Developmental Neurobiology

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“…Durante o processo de analise da flibanserina pelo FDA, uma associação chamada Empate o Jogo (Even the Score) 20 acusou o FDA de sexismo pela existência de 26 medicamentos para a disfunção masculina e nenhum para a feminina. O grupo, criado por uma consultora da indústria produtora de flibanserina que anteriormente chefiou o escritório de Saúde da Mulher do FDA, promoveu uma campanha de advocacy, 21…”

Section: Em Linhas Gerais Esses Estudos Clínicos Indicaram Que 18unclassified

Development and Syntheses of Flibanserin (Addyi^®) - "the Female Viagra^®"

Barros¹,

Cotrim²

2016

Revista Virtual De Química

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“…Flibanserin was originally developed as an antidepressant[ 3 ] with a potentially rapid onset of action;[ 4 ] it was effective in some but not all animal models of depression. [ 5 ] Phase 2 randomized controlled trials (RCTs) failed to find it effective against depression; however, interestingly, the drug outperformed placebo on responses to the question “how strong is your sex drive.”[ 3 ]…”

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confidence: 99%

“…The flibanserin data for HSDD had twice been presented to the FDA, and the application for approval was rejected both times on the grounds that the risk-benefit ratio was unfavorable. [ 3 ] On August 18, 2015, however, after reviewing additional data, the FDA approved flibanserin for acquired, generalized HSDD in premenopausal women with the caveat that the drug be dispensed through a special risk management program. No other treatment has been approved for this indication.…”

mentioning

confidence: 99%