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Treating Postpartum Depression: What Do We Know about Brexanolone?

Postpartum depression (PPD) is defined as the onset of major depressive disorder in mothers, occurring during pregnancy or within 4 weeks post-delivery. With 7% of pregnancy-related death in the United States owing to mental health conditions, including PPD, and a global prevalence of 12%, PPD is a...

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Autores principales: Ali, Muneeza, Aamir, Alifiya, Diwan, Mufaddal Najmuddin, Awan, Hashir Ali, Ullah, Irfan, Irfan, Muhammad, De Berardis, Domenico
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293057/
https://www.ncbi.nlm.nih.gov/pubmed/34287271
http://dx.doi.org/10.3390/diseases9030052
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author Ali, Muneeza
Aamir, Alifiya
Diwan, Mufaddal Najmuddin
Awan, Hashir Ali
Ullah, Irfan
Irfan, Muhammad
De Berardis, Domenico
author_facet Ali, Muneeza
Aamir, Alifiya
Diwan, Mufaddal Najmuddin
Awan, Hashir Ali
Ullah, Irfan
Irfan, Muhammad
De Berardis, Domenico
author_sort Ali, Muneeza
collection PubMed
description Postpartum depression (PPD) is defined as the onset of major depressive disorder in mothers, occurring during pregnancy or within 4 weeks post-delivery. With 7% of pregnancy-related death in the United States owing to mental health conditions, including PPD, and a global prevalence of 12%, PPD is a growing public health concern. In 2019, the Food and Drug Administration (FDA) approved brexanolone, an exogenous analog of allopregnanolone, as the first ever drug to be specifically indicated for treating patients with PPD. This approval was preceded by an open-label study and three randomized placebo-controlled trials, each assessing the safety, tolerability, and efficacy of brexanolone, using mean Hamilton Rating Scale for Depression (HAM-D) score reduction as the primary outcome. In each randomized controlled trial, the drug was administered as an intravenous infusion given over 60 h. Enrolled participants were followed up on days 7 and 30 to evaluate the sustained effect. A statistically significant reduction in mean HAM-D score compared to placebo was observed in all three studies, supporting brexanolone’s use in treating moderate-to-severe PPD. Therefore, this article attempts to briefly review the pharmacology of brexanolone, evaluate the latest available clinical data and outcomes concerning its use, reevaluate its position as a ‘breakthrough’ in managing PPD, and review the cost-related barriers to its worldwide standardized use.
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spelling pubmed-82930572021-07-22 Treating Postpartum Depression: What Do We Know about Brexanolone? Ali, Muneeza Aamir, Alifiya Diwan, Mufaddal Najmuddin Awan, Hashir Ali Ullah, Irfan Irfan, Muhammad De Berardis, Domenico Diseases Review Postpartum depression (PPD) is defined as the onset of major depressive disorder in mothers, occurring during pregnancy or within 4 weeks post-delivery. With 7% of pregnancy-related death in the United States owing to mental health conditions, including PPD, and a global prevalence of 12%, PPD is a growing public health concern. In 2019, the Food and Drug Administration (FDA) approved brexanolone, an exogenous analog of allopregnanolone, as the first ever drug to be specifically indicated for treating patients with PPD. This approval was preceded by an open-label study and three randomized placebo-controlled trials, each assessing the safety, tolerability, and efficacy of brexanolone, using mean Hamilton Rating Scale for Depression (HAM-D) score reduction as the primary outcome. In each randomized controlled trial, the drug was administered as an intravenous infusion given over 60 h. Enrolled participants were followed up on days 7 and 30 to evaluate the sustained effect. A statistically significant reduction in mean HAM-D score compared to placebo was observed in all three studies, supporting brexanolone’s use in treating moderate-to-severe PPD. Therefore, this article attempts to briefly review the pharmacology of brexanolone, evaluate the latest available clinical data and outcomes concerning its use, reevaluate its position as a ‘breakthrough’ in managing PPD, and review the cost-related barriers to its worldwide standardized use. MDPI 2021-07-12 /pmc/articles/PMC8293057/ /pubmed/34287271 http://dx.doi.org/10.3390/diseases9030052 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Ali, Muneeza
Aamir, Alifiya
Diwan, Mufaddal Najmuddin
Awan, Hashir Ali
Ullah, Irfan
Irfan, Muhammad
De Berardis, Domenico
Treating Postpartum Depression: What Do We Know about Brexanolone?
title Treating Postpartum Depression: What Do We Know about Brexanolone?
title_full Treating Postpartum Depression: What Do We Know about Brexanolone?
title_fullStr Treating Postpartum Depression: What Do We Know about Brexanolone?
title_full_unstemmed Treating Postpartum Depression: What Do We Know about Brexanolone?
title_short Treating Postpartum Depression: What Do We Know about Brexanolone?
title_sort treating postpartum depression: what do we know about brexanolone?
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8293057/
https://www.ncbi.nlm.nih.gov/pubmed/34287271
http://dx.doi.org/10.3390/diseases9030052
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