Tag Archives: Brexanolone

Brexanolone (Zulresso) for Postpartum Depression Cleared by the DEA, Now Available

Brexanolone, to be marketed by Sage Therapeutics as Zulresso, was initially approved in March 2019, as a treatment for postpartum depression.  At that time, we were told that Zulresso would be available in June 2019. Here are a few updates. The Drug Enforcement Administration (DEA) has recommended that brexanolone be placed in schedule IV of… Read More »

FDA Supports Intravenous Brexanolone for 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. This… 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 »