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 and Adult Female Subjects With Moderate Postpartum Depression

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 and Adult Female Subjects With Moderate Postpartum Depression

Completed
Phase of Trial: Phase III

Latest Information Update: 30 May 2018

At a glance

  • Drugs Brexanolone (Primary)
  • Indications Postnatal depression
  • Focus Registrational; Therapeutic Use
  • Acronyms Hummingbird Study
  • Sponsors Sage Therapeutics
  • Most Recent Events

    • 30 May 2018 According to a SAGE Therapeutics media release, based on the data from Hummingbird Program (Study 202B and Study 202C), the US FDA has accepted the filing of a New Drug Application (NDA) of brexanolone (SAGE-547) for the treatment of postpartum depression (PPD).
    • 03 May 2018 According to a SAGE Therapeutics media release, results from this study were presented at the North American Society for Psychosocial Obstetrics and Gynecology (NASPOG) 2018.
    • 03 May 2018 According to Sage therapeutics media release, the company anticipated that the FDA will accept the NDA filing in Q2 2018, and if approved, the drug will launch in the first half of 2019 in USA.
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