FDA Approves First-Ever Drug for Postpartum Depression

(CN) — Giving hope to the 1 in 9 women who experience postpartum depression, the U.S. Food and Drug Administration approved the first drug to treat PPD.

A product from Massachusetts-based Sage Therapeutics, Zulresso relies on the active ingredient brexanolone to mimic the naturally occurring hormone progesterone, which tends to plunge after childbirth.

Samantha Meltzer Brody, a researcher with the School of Medicine at University of North Carolina, had been the primary investigator of the Zulresso clinical trials.

Announcing the FDA’s approval of the drug Tuesday, Brody noted that PPD is the most common medical complication after childbirth, which is why it is so important to tackle.

“The potential to rapidly reduce symptoms in this critical disorder is an exciting milestone in women’s mental health,” Brody said in a statement. “PPD is recognized to have a significant and long-term impact on women and their families, but with Zulresso we may finally have the opportunity to change that.” 

Tiffany Farchione, director of Psychiatry Products for the FDA’s Center for Drug Evaluation and Research, touted the the importance of the drug as well.

“Postpartum depression is a serious condition that, when severe, can be life-threatening,” Farchione said in a statement. “Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”

The most common side effects of Zulresso, which is administered through an IV drip over a continuous 60 hours, rather than in pill form, are dizziness and unconsciousness.

The FDA noted, because of the possible risks, Zulresso will be administered only through a program where recipients must be enrolled at a certified location. Sage expects to begin selling Zulresso in June.

Without insurance, an infusion of Zulresso comes at the hefty price tag of $34,000 — an amount that does not include the cost of staying at the certified center for the 2 ½ days. 

Brexanolone stems from research done by the National Institutes of Mental Health in the 1980s on stress levels of rats during their reproductive cycle. Representatives for NIH did not immediately respond to email seeking comment.

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