First Ever FDA-Approved PPD Treatment

Samantha Meltzer-Brody, M.D., M.P.H.

UNC Department of Psychiatry

Assad Meymandi Distinguished Professor and Chair of Psychiatry
Director, UNC Center for Women’s Mood Disorders

Performed the first study of a novel compound – a neurosteroid – for rapid treatment of postpartum depression, a treatment that will soon be available to the 10-15% of women who develop postpartum depression.

As a perinatal psychiatrist and clinician-scientist, Dr. Meltzer-Brody’s  proudest and highest impact research accomplishment is serving as the academic PI for the brexanolone clinical trials in the treatment of postpartum depression (PPD). Now approved by the FDA, this is the first pharmacotherapy specifically developed and approved for PPD. PPD is a debilitating mental illness that impacts at least 10-15% of women that give birth.

This research is directly tied to Dr. Meltzer-Brody’s long-term interest in understanding the pathophysiology and biomarker signature of PPD (funded by Foundation of Hope), with the goal of developing novel therapies and improving outcomes for our patients.

The team at the UNC Center for Women’s Mood Disorders conducted the first open-label study of brexanolone almost five years ago and participated in the phase 2 and 3 clinical trials with the study sponsor (Sage Therapeutics). Brexanolone is a proprietary formulation of allopregnanolone, a neuroactive metabolite of progesterone. It has a unique pharmacologic mechanism (positive allosteric modulator of GABA-A) that makes it a novel therapy.

Brexanolone has a rapid onset of action (response within the first 24 hours) of a 60-hour infusion, leading to a robust treatment response, which has shown durability through the 30 days of the study follow-up period. This is a completely new model for treating postpartum depression. Consequently, brexanolone will be a powerful new treatment tool that has the ability to quickly and meaningfully relieve suffering within days.