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The U.S. Food and Drug Administration has approved a drug meant to specifically treat postpartum depression in mothers, a first for the agency.
The FDA announced in a news release Tuesday that it approved an intravenous infusion of brexanolone, a drug labeled as Zulresso. Patients would receive a continuous IV drip over 60 hours. The news release said clinical trials, which involved more than 200 women, showed brexanolone worked within hours to help treat postpartum depression, which affects 1 in 9 new mothers.
Postpartum depression is much more severe and longer-lasting than the “baby blues” many new mothers experience for about a week after giving birth. Symptoms of postpartum depression can include sadness, loss of interest, difficulty bonding with the baby and even suicidal thoughts.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond,” said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”