FDA Supports Intravenous Brexanolone for Postpartum Depression

By | November 10, 2018

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 week the US Food and Drug Administration (FDA) advisory panel voted unanimously in favor of approval for brexanolone intravenous infusion for the treatment of PPD.  

One of the obvious downsides of brexanolone is that it must be given intravenously and thus may require inpatient hospitalization in order to administer.  Although this might seem like an obstacle, I suspect that many women with severe PPD would easily sign on for this type of treatment if they had a significant chance of improving within a few days.  We could also argue that being in the hospital, even for a few days, might be beneficial, in that it could provide some respite from the demands of caring for a newborn. However, this will significantly increase the cost of treatment.

Brexanolone represents a novel approach to the treatment of postpartum mood disorders.  One of the most exciting things about brexanolone is the rapidity of the response — remission of depression within 24 to 48 hours!  Because antidepressants typically take 2-4 weeks to kick in, an antidepressant agent with rapid onset of action would be particularly appealing to women with severe PPD, including women with suicidality.  

The FDA has some concerns regarding two serious adverse events: suicidal ideation after the infusion in one subject and syncope/altered consciousness in another patient.  The FDA will require the manufacturer to provide specific guidelines related to the management of these adverse events, but the  FDA does not see this as an obstacle to bringing the drug to market.

Ruta Nonacs, MD PhD

Read More:

FDA Panel Backs Novel Treatment for Postpartum Depression (Medscape – free subscription)

FDA advisory committees support ‘game-changing’ drug brexanolone for postpartum depression (Healio)

MGH Center for Women's Mental Health