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A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating The Efficacy, Safety, And Pharmacokinetics Of SAGE-547 Injection In The Treatment Of Adult Female Subjects With Severe Postpartum Depression

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Trial Profile

A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating The Efficacy, Safety, And Pharmacokinetics Of SAGE-547 Injection In The Treatment Of Adult Female Subjects With Severe Postpartum Depression

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 15 Sep 2021

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At a glance

  • Drugs Brexanolone (Primary)
  • Indications Postnatal depression
  • Focus Proof of concept; Registrational; 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
  • 19 Mar 2019 According to a SAGE Therapeutics media release, based on the three pivotal studies (Study 202B, Study 202C and 202A), the US FDA has approved ZULRESSO (brexanolone) injection for the treatment of postpartum depression (PPD).

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