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An Open-Label Proof-of-Concept Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-547 Injection in the Treatment of Adult Female Patients With Severe Postpartum Depression

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Trial Profile

An Open-Label Proof-of-Concept Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-547 Injection in the Treatment of Adult Female Patients With Severe Postpartum Depression

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 07 Dec 2021

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At a glance

  • Drugs Brexanolone (Primary)
  • Indications Postnatal depression
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors Sage Therapeutics

Most Recent Events

  • 21 Mar 2020 Results assessing Population pharmacokinetics (PopPK) of brexanolone in three randomized studies, an open label study and one study of healthy lactating women, presented at the 121st Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.
  • 19 Feb 2020 Results of review of four studies (NCT02942004, NCT02942017, NCT02614547, NCT02285504) published in the American Journal of Health-System Pharmacy
  • 28 Mar 2016 According to Sage media release, the company will present data from this study at the Society of Biological Psychiatry 71st Annual Scientific Meeting.

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