FDA Approves First Ever Drug to Treat Postpartum Depressionadmin
The FDA officially approved the first ever treatment for postpartum depression (PPD) on Tuesday.
“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. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research said in a press release.
PPD is a major depressive episode that occurs following childbirth and is the most common complication of pregnancy, according to The New York Times. As many as one in seven women will experience depression during or after pregnancy.
The drug, Zulresso (brexanolone), works within 48 hours, unlike many other popular antidepressants which can take up to four weeks to have an effect, if they have any effect at all. It is administered via infusion over 60 hours, during which the mother must remain under medical supervision in a certified medical center.
Trials for this medication involved 247 women who had given birth within six months of getting the infusion and were experiencing severe to moderate depression that had started in the third trimester of pregnancy or within four weeks after childbirth. They were randomly selected to receive either the placebo or brexanolone. After a month, more brexanolone patients managed to keep their depression at bay than those who received the placebo.
Researchers are also currently working on a pill that contains the same molecule found in Zulresso that would be more easily accessible, easier to administer, and less expensive. Currently, when administered for two weeks in the clinical trials, this medication seems to offer the same benefits as infusion.