Zulresso Approved to Treat Postpartum Depression
March 19, 2019 – The U.S. FDA has approved Zulresso™ (brexanolone) injection, manufactured by Sage Therapeutics, to treat postpartum depression (PPD) in adult women. It is the first drug to receive FDA approval specifically to treat PPD.
Postpartum depression affects an estimated one in nine women in the United States annually, according to the Centers for Disease Control and Prevention (CDC). Individuals with PPD may experience symptoms that include withdrawal from social and everyday activities; intense and persistent sadness; feelings of anger, doubt, or guilt; and thoughts of self-harm or of harming the infant. Risk factors for PPD range from a family history of depression to difficulties and stress during or after pregnancy. PPD is typically treated with a combination of counseling and medication.
In clinical studies, Zulresso produced a significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score, a common measure of depression severity, at 60 hours compared to placebo. Improvement in symptoms was observed as soon as 24 hours following administration, with effects maintained through the 30-day follow-up period.
Zulresso will only be available through a Risk Evaluation and Mitigation Strategy (REMS) due to risks of serious harm from excessive sedation or sudden loss of consciousness. It also carries a black box warning advising of these risks. Under the recommended dosing, the drug requires a continuous 60-hour infusion at a variable rate. Patients must receive the infusion from a trained healthcare professional and in a monitored health setting that is equipped to intervene as necessary throughout the course of the infusion.
Sage Therapeutics expects to launch Zulresso in June, pending U.S. Drug Enforcement Administration (DEA) controlled substance scheduling.