FDA approves first drug for postpartum depression

The first drug for women suffering postpartum depression received federal approval last week, a move likely to pave the way for a wave of treatments to address a debilitating condition that is the most common complication of pregnancy.

The drug, a synthetic version of a naturally occurring hormone, may be a significant improvement over currently available antidepressants because it works quickly, within 48 hours.

That may be especially helpful in circumstances in which depression keeps mothers from providing their babies with the care, bonding and nurturing that is crucial for healthy development. Most antidepressants take two to four weeks to ease symptoms, if they work at all.

“Postpartum depression is a serious condition that, when severe, can be lifethreatening,” Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement.

“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”

There are limitations to the new drug, brexanolone, which will be marketed as Zulresso. It is delivered by infusion over 60 hours, during which a new mother must remain in a certified medical center, under supervision should she get dizzy or faint, as several patients did in clinical trials.

The infusion will be expensive, between $20,000 and $35,000, not including the costs of staying in the medical center for 2 days.

A pill version, which would be much more accessible and easier for patients, is showing promise in its clinical trials and would be submitted for approval in a couple of years if the results are good, according to the manufacturer, Sage Therapeutics.

The infusion is to be administered just once. Company officials say they expect that insurers will cover the treatment; insurers said last week that they are evaluating the drug.

Clinical trials of the drug, all sponsored by Sage, found that it produced a steeper decrease in symptoms in women with severe and moderate postpartum depression than a similar placebo infusion.

The relief from depression continued for a month after the treatment. There has not been systematic research on longer-term results.

“The major thing is, of course, the rapid effect,” said Dr. Margaret Spinelli, a clinical professor of psychiatry at Columbia University, who treats and studies postpartum depression and was not involved in the research on brexanolone.

“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,” she added.