A Breakthrough for Post-partum Depression

Last month, the FDA approved Zulresso (brexanolone), the first drug specifically indicated to treat postpartum depression (PPD), a major depressive episode that affects an estimated 15 percent of women following childbirth.   Up to 70 percent of  new mothers experience the “baby blues” and exhibit emotional lability, irritability, and anxiety that typically last a couple of weeks and resolve on their own without treatment.  PPD is different.  It’s a much more serious and debilitating condition which may continue for months and is characterized by sadness, apathy, anhedonia, cognitive impairment, feelings of worthlessness and/or guilt, thoughts of harm (to oneself or the baby), and even suicidal ideation.   

Unlike other antidepressants, Zulresso is administered via intravenous infusion over 60 hours and has a different mechanism of action.  Its active ingredient is a synthetic progesterone derivative, allopregnanolone, which acts on the main inhibitory neurotransmitter system in the brain, the GABA system, to modulate the stress response.  In addition, unlike other marketed oral antidepressants which can take several weeks to be effective, in clinical trials the drug was shown to reduce the severity of depression within 24-48 hours.

The drug has an anticipated cost of $20,000 to $35,000 per patient for the infusion alone and should be available in June 2019 through the "Zulresso Risk Evaluation and Mitigation Strategy (REM)S Program," which requires administration by a health care provider in a certified health care facility where the patient can be closely monitored for excessive sedation and sudden loss of consciousness (boxed warning).  Safety in breast-feeding is still to be determined by the FDA.


Judith Wolf, MD    Associate Director, WHEP