On Tuesday, the U.S. Food and Drug Administration (FDA) has approved the first drug called brexanolone for women who suffer from postpartum depression.
This approval is likely to pave the way for the treatments that address postpartum depression, a debilitating condition and a common complication of pregnancy.
The drug has been found to work very quickly, within 48 hours, while the current antidepressants take time, maybe around three to four weeks if they work at all.
Researchers say that the new drug will offer prompt relief from postpartum depression that keeps mothers from providing good care to their babies. One in seven women in the United States experience post-partum depression.
Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the FDA’s Center for Drug Evaluation and Research, said, “Postpartum depression is a serious condition that, when severe, can be life-threatening. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
However, there are a few limitations to brexanolone, which will be sold under the brand name Zulresso. The drug is administered through infusion for 60 hours and the mother receiving the drug must remain in a medical center under the supervision of a doctor to see whether she gets dizzy or drowsy.
Brexanolone infusion will be quite expensive. It could cost $34,000 per patient, according to its manufacturer, Sage Therapeutics. And that does not include the cost of a 60-hour stay in a medical center. The officials of Sage Therapeutics say they are expecting that insurers will cover the treatment. Health insurers said that they are evaluating brexanolone.
A tablet made with a similar chemical, which could be much more accessible and easier, has been showing promising results in its clinical trials. Sage says that if the results are good, it would submit the drug for approval in a couple of years.
Brexanolone infusion is to be taken only once, and patients may use standard antidepressants. According to Sage, clinical trials have found that brexanolone produced a considerable reduction in symptoms of severe and moderate postpartum depression than placebo infusion. And the relief from postpartum depression continued for a month post-treatment.
Dr. Margaret Spinelli, a clinical professor of psychiatry at Columbia University, said, “The major thing is, of course, the rapid effect. That it’s the first that’s designed for postpartum depression is important and means it will probably be a segue to design other medications for postpartum depression to be administered in an easier way.” Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina at Chapel Hill, said, “Brexanolone is a synthetic form of allopregnanolone, a hormone produced by progesterone in the brain that may help ease depression and anxiety by dampening neural activity.”
