The US Food and Drug Administration (FDA) has approved the first drug to be indicated for the treatment of postpartum depression (PPD) in women. Brexanolone (Zulresso), which will be given intravenously over 60 hours, is expected to be available in late June, drugmaker Sage Therapeutics announced.
The approval “represents a game-changing approach to treating PPD,” said Samantha Meltzer-Brody, MD, MPH, director of the Perinatal Psychiatry Program at the University of North Carolina’s Center for Women’s Mood Disorders and primary investigator of the brexanolone clinical trials. “The potential to rapidly reduce symptoms in this critical disorder is an exciting milestone in women’s mental health.”
Sage has reported that the average projected list price for the treatment is $34,000 before any discounts.
Brexanolone was approved with a Risk Evaluation and Mitigation Strategy (REMS) and must be given at a certified health care facility under monitoring by a health care provider "because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration,” according to the FDA.
Patients will need to enroll in the REMS program before the treatment and have continuous pulse oximetry monitoring during the infusion. They must also be accompanied while interacting with their children during the treatment. The drug will carry a Boxed Warning explaining the need for these steps.
Brexanolone, an allosteric modulator of synaptic and extrasynaptic GABAA receptors, was evaluated by the FDA under Priority Review and in 2016 was granted Breakthrough Therapy Designation status.
The drug, formerly known as SAGE-547, was studied in 3 multicenter, randomized, double-blind, parallel-group, placebo-controlled trials involving women with moderate and severe PPD. In all trials, all doses of the drug achieved the primary endpoint, a significant mean reduction in the Hamilton Rating Scale for Depression (HAM-D) total score, after 60 hours, compared with placebo. Effect was seen after as little as 24 hours and maintained through 30 days.
Sleepiness, dry mouth, loss of consciousness, and flushing were the most common adverse events in the studies.
PPD, which can occur during pregnancy or after childbirth, is estimated to affect about 1 in 9 women who give birth in the United States, and up to half of those cases may go undiagnosed without proper screening, according to Sage. In severe cases, women could have thoughts about harming themselves or their child.
An oral version of the drug, SAGE-217, is being developed by Sage. It is in phase 3 studies for the treatment of major depressive disorder and postpartum depression.
Sage Therapeutics announces FDA approval of Zulresso™ (brexanolone) injection, the first and only treatment specifically indicated for postpartum depression [press release]. Cambridge, Massachusetts: Sage Therapeutics; March 20, 2019.