FDA Approves First Treatment for Postpartum Depression

The U.S. Food and Drug Administration today approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.

PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. Up until now, there were no specifically approved drugs to treat symptoms. Thanks to a recent study at Ohio State however, women with PPD now have a new treatment option.

The study, led by Ohio State researchers Tamar Gur, MD  and Anne-Marie Duchemin, PhD , and with the assistance of the Ohio State Clinical Research Center (CRC) , admitted adult participants with Postpartum Depression (within 6 months of delivery) to the CRC for a 72-hour inpatient stay.  The participants received 60 hours of continuous infusion with titration of the study medication versus placebo.

Participants required close monitoring for safety and data integrity including: continuous pulse oximetry monitoring, timed orthostatic vital signs, timed pharmacokinetics, sedation monitoring, EKGs, depression scale assessment and monitoring for any side effects in relation to administration of the study medication.

Zulresso will be available only through a restricted program called the Zulresso REMS Program that requires the drug be administered by a health care provider in a certified health care facility.

The CRC assisted with this study by providing nursing staff, processing lab and research nutrition for the intense data collection required.