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FDA Approves First Oral Postpartum Depression Treatment, Zuranolone
The US Food and Drug Administration (FDA) approved Zurzuvae (zuranolone) on Friday through a fast-track designation, making it the first oral medication designed for the treatment of postpartum depression (PPD) in adults. Until now, PPD treatment was only available as an intravenous injection (brexanolone) administered in certain healthcare facilities.
“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” the FDA Center for Drug Evaluation and Research’s director of the Division of Psychiatry, Tiffany R. Farchione, MD, said in a news release.
Zuranolone‘s efficacy was demonstrated through 2 randomized, double-blind, placebo-controlled, multicenter clinical trials involving women who met the criteria for a major depressive episode as defined by the Diagnostic and Statistical Manual of Mental Disorders. Particpants were treated with zuranolone for 14 days, and the primary endpoint comprised change in depressive symptoms using the Hamilton depression rating scale at day 15. Participants receiving zuranolone showed significant improvement in their symptoms compared to the placebo groups, and this effect was maintained for at least 4 weeks after treatment.
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The recommended daily dose for Sage Therapeutic, Inc.’s zuranolone is 50-mg, taken once daily in the evening with a fatty meal for 14 days.
Zuranolone comes with a boxed warning, noting that the drug can affect a person's ability to drive and perform hazardous activities with increased risk for at least 12 hours after taking the drug.
Common side effects include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (the common cold), and urinary tract infections. Zuranolne may also trigger suicidal thoughts and behavior. The drug may cause fetal harm, so women are advised to use effective contraception while taking it and for 1 week after discontinuing its use.
“Postpartum depression is a serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child,” Dr Farchione said. “And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.”
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