FDA approves Zulresso to treat postpartum depression

Sage Therapeutics announced the FDA has approved Zulresso (brexanolone) injection for the treatment of postpartum depression (PPD). Zulresso is the first and only medicine specifically approved to treat PPD, the most common medical complication of childbirth. Zulresso is expected to be available in late June following scheduling by the U.S. Drug Enforcement Administration, which is expected to occur within 90 days.

The FDA approval of Zulresso is based on findings from three multicenter, randomized, double-blind, parallel-group, placebo-controlled trials, designed to evaluate the safety and effectiveness of Zulresso in women with moderate and severe PPD, aged between 18 and 45 years who were more than six months postpartum at screening and who had onset of symptoms no earlier than the third trimester and no later than the first four weeks following delivery. In all trials at all doses, Zulresso achieved the primary endpoint, 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. A reduction of depressive symptoms was also seen as early as 24 hours, and Zulresso maintained effect through the 30-day follow-up. The most common adverse events in the studies were sleepiness, dry mouth, loss of consciousness and flushing.

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 REMS requires that patients be enrolled in the program prior to administration of the drug. Zulresso is administered as a continuous IV infusion over a total of 60 hours (2.5 days). Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood).

Comment: Sage Therapeutics has in development SAGE 217 an oral therapy with a similar mechanism of action to Zulresso that is focused on PPD as well as major depressive disorder.