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Postpartum depression pill approval overview:
- Who: The U.S. Food and Drug Administration (FDA) has approved the drug Zuranolone to be sold under the brand name Zurzuvae as the first oral medication that can be used to treat postpartum depression in adults.
- Why: The FDA said access to an oral medication for postpartum depression can help women who are dealing with the depressive condition.
- Where: Nationwide.
The U.S. Food and Drug Administration (FDA) announced Aug. 4 that it has approved the first oral medication for treating postpartum depression in adults.
Treatment for postpartum depression was previously limited to IV injections that could only be administered by health care providers in certain healthcare facilities, according to the FDA.
“Having access to an oral medication will be a beneficial option for many … women coping with extreme, and sometimes life-threatening, feelings,” said Tiffany R. Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, in a statement.
Postpartum depression is characterized by feelings of sadness or loss of interest in activities that an individual used to enjoy, along with a decreased feeling of pleasure overall, according to the FDA.
Farchione, meanwhile, called postpartum depression a “serious and potentially life-threatening condition” that can cause women to experience negative thoughts, and, in severe cases, make them consider hurting themselves or their child.
“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,” Farchione said.
Efficacy of oral postpartum depression medication demonstrated in randomized double-blind, placebo-controlled studies
The newly FDA-approved oral postpartum depression medication is Zuranolone that is being sold under the brand name Zurzuvae. The drug’s efficacy was demonstrated in two randomized studies that were double-blind and placebo-controlled, according to the FDA.
“Patients in the Zurzuvae groups showed significantly more improvement in their symptoms compared to those in the placebo groups,” the FDA said. “The treatment effect was maintained at Day 42—four weeks after the last dose of Zurzuvae.”
The study consisted of women suffering from postpartum depression who experienced a major depressive episode — under criteria set by the Diagnostic and Statistical Manual of Mental Disorders — with symptoms that began in their third trimester or within four weeks of delivery.
The recommended daily dose for Zurzuvae is 50mg once per day — taken during a “fatty” meal — for a total of 14 days, according to the FDA.
The most common side effects of Zurzuvae include dizziness, diarrhea, fatigue, drowsiness, the common cold, and urinary tract infection. The medication was submitted to the FDA for approval in February, reports WebMD.
The FDA approved birth control pill Opill for availability both over-the-counter and without a prescription last month. The agency explained that doing so could “reduce barriers” for getting oral contraceptives and help prevent unintended pregnancies.
Could you or a loved one benefit from taking the newly FDA approved oral medication for treating postpartum depression? Let us know in the comments!
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