Tag Archives: Brexanolone

FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression

FDA Approves Zulresso (brexanolone) for the Treatment of Postpartum Depression Print this page March 19, 2019 — The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD. “Postpartum depression… Read More »

FDA is Expected to Approve Brexanolone for the Treatment of Postpartum Depression

In 2015, we first reported on SAGE-547 (SAGE Therapeutics), a new medication for the treatment of postpartum depression (PPD).  SAGE-547, now called brexanolone, is an allosteric modulator of GABAA receptors.  Since that time, Sage Therapeutics has conducted three randomized controlled trials, enrolling a total of 247 women diagnosed with moderate to severe postpartum depression. It… Read More »

Brexanolone for Postpartum Depression: More Data, But Still Some Questions

In 2015, we first reported on SAGE-547 (SAGE Therapeutics), a new medication for the treatment of severe postpartum depression (PPD).  SAGE-547, now called brexanolone, is an allosteric modulator of GABA-A receptors.  We saw the preliminary results of the Sage Therapeutics Phase 3 Hummingbird Program earlier this year.  Now we have the final set of results… Read More »