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
Phase of Trial: Phase III
Latest Information Update: 20 Nov 2017
At a glance
- Drugs Brexanolone (Primary)
- Indications Postnatal depression
- Focus Registrational; Therapeutic Use
- Acronyms Hummingbird Study
- Sponsors Sage Therapeutics
- 10 Nov 2017 Status changed from active, no longer recruiting to completed.
- 09 Nov 2017 According to a Sage Therapeutics media release, the company believes that the data from the trial will be sufficient to support submissions of regulatory applications seeking approval of brexanolone for PPD and plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in 2018.
- 09 Nov 2017 According to a Sage Therapeutics media release, detailed study results, including additional secondary endpoints, will be submitted for presentation at an upcoming medical meeting and for publication.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History