Topline
The Food and Drug Administration approved a medication intended to treat postpartum depression on Friday, the first oral treatment to treat the depressive disorder that affects an estimated one in seven women after childbirth.
Key Facts
The FDA approved the drug zuranolone, manufactured in pill form as “Zurzuvae” by Sage Therapeutics and Biogen, which said can the drug “provide rapid improvements” for women experiencing symptoms of postpartum depression, which include cognitive impairment, feelings of sadness or inadequacy, loss of energy, or thoughts of suicide.
Zuranolone works as a neuroactive steroid that bonds to GABA receptors in the brain, which resets neurotransmitters that are unbalanced in people with some disorders, including depression, schizophrenia and other mood disorders.
Zurzuvae was tested in two randomized, double-blind tests—tests where neither the participant nor the experimenters know who is receiving placebos—that indicated patients that received 50 milligrams of Zurzuvae “showed significantly more improvement” in their symptoms after 15 days compared to a placebo group.
Kristina Deligiannidis, director of women’s behavioral health at New York-based Zucker Hillside Hospital, told Fortune the drug is notable because it can provide a “rapid reduction of depressive symptoms” as early as three days.
The FDA also requested additional studies of the drug on adults that experience other major depressive disorders—which affect an estimated 8.3% of American adults—according to both companies, which said they are “evaluating next steps.”
The companies said the pill will become commercially available after the FDA schedules the pill as a controlled substance, which is expected to happen within 90 days.
Crucial Quote
Samantha Meltzer-Brody, director of the Center For Women’s Mood Disorders at the University of North Carolina at Chapel Hill, told the Washington Post the drug “is going to be a game changer for treating maternal depression.”
Big Number
500,000. That’s the estimated number of women in the U.S. that experience symptoms of postpartum depression each year, according to Postpartum Support International.
Key Background
Postpartum depression—often referred to as “baby blues”—is experienced by some women after childbirth, though most tend to experience fewer symptoms two weeks after delivery. Symptoms often start within the first two to three days after giving birth—and sometimes during pregnancy—and may last for several years. As many as half of mothers who experience postpartum depression do not disclose their symptoms. An estimated 20% of all maternal deaths after giving birth are attributed to suicide, according to the Policy Center for Maternal Mental Health. Prior to the FDA’s approval of zuranolone, the only federally approved option for treating postpartum depression was brexanolone, a drug marketed as Zulresso that is only available through an IV infusion.
Further Reading
FDA Approves Oral Pill For Postpartum Depression For First Time (Reuters)
FDA Approves Zuranolone, First Pill For Postpartum Depression (CBS)
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