FDA Approves First Drug Treatment for Postpartum Depression

The U.S. Food and Drug Administration (FDA) has approved a drug for the first time that aims at treating postpartum depression in mothers.

Dubbed Zulresso, the medication is administered by a continuous intravenous (IV) infusion for 60 hours. According to the FDA, the IV must be administered in a health care facility because of fears of “serious harm due to sudden loss of consciousness.” Patients also need to be accompanied by another adult when they have their children with them during treatment.

Despite those concerns, the FDA found Zulresso, which is owned by Sage Therapeutics, to be effective in treating postpartum depression. In two clinical studies, women with either severe postpartum depression or moderate postpartum depression saw marked improvements in their depressive symptoms compared to a placebo group. The effects were apparent after the first infusion and were still there at the 30-day follow-up appointment, according to the FDA.

Postpartum depression is a major depressive disorder that can affect women both during pregnancy and after childbirth. It’s often associated with varying levels of sadness, an inability to feel pleasure, and in severe cases, suicidal thoughts. In some cases, mothers may have thoughts of harming their children.

Whether Zulresso will actually be used in widespread cases remains to be seen. The 60-hour treatment window in a healthcare facility for a mother who’s raising one or more children might be difficult to accommodate. And according to CNN, a single treatment could range from $20,000 to $35,000, making the treatment cost prohibitive to some mothers.