By Brittany Shoot
November 2, 2018

The United States Food and Drug Administration (FDA) seems poised to approve brexanolone, a postpartum depression drug developed by Sage Therapeutics. There are currently no FDA-approved drugs to specifically treat postpartum depression, a much more extreme version of the so-called “baby blues” some women experience after childbirth.

Some side effects caused the FDA to recommend a monitoring period after women receive the injection, and recommend against home use of the drug. Six of the 140 women exposed to brexanolone in clinical trials experienced sedation, at least one losing consciousness related to the drug, and another suffering from sleep apnea, according to an FDA briefing document available after the agency’s Nov. 2 hearing on managing the psychopharmacologic treatment.

But the small sampling of individuals that experienced those side effects doesn’t really compare with the devastating impacts of postpartum depression on mothers, their children, and their families. Postpartum depression (PPD) is typically treated with antidepressants, which can take four to six weeks to kick in. That’s a timeline that doesn’t serve PPD sufferers well, given that the extreme nature of PPD can leave new mothers feeling hopeless, restless, or even suicidal, according to the Mayo Clinic. PPD can last for months or longer, and that can impact parents’ ability to care for their children and create the potential for lasting effects of a new mom’s depression.

If generic brexanolone is approved, Sage Therapeutics plans to move ahead on seeking approval for the brand name of the injection, Zulresso. The drug would be available in a 5 mg injection form.

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