Drug for postpartum depression is approved

The Food and Drug Administration on Tuesday approved the first drug specifically for postpartum depression — a debilitating condition that affects hundreds of thousands of women a year in the United States.

The disorder, which begins during pregnancy or within a month of childbirth, is characterized by feelings of worthlessness or guilt, or thoughts of suicide and is far more severe than the common “baby blues.” The condition can interfere with a mother’s ability to bond or with an infant, which can affect the baby’s development. An estimated 400,000 women in the United States each year suffer from postpartum depression.

The newly approved drug, called brexanolone, will be marketed under the name Zulresso. Its manufacturer, Sage Therapeutics in Cambridge, Massachusetts, said the drug would likely cost $20,000 to $35,000 for a course of treatment.

The medication must be administered intravenously for 60 continuous hours and — under an FDA safety program that accompanied its approval — under the supervision of a health care professional, in a doctor’s office or a clinic, for example.

Experts called the drug a major advance for a serious illness that does not get enough attention. “We don’t have any treatments that are anywhere near this effective,” said Jess Fiedorowicz, a psychiatrist at the University of Iowa and a member of an FDA advisory panel that recommended agency approval of the drug. “So this is groundbreaking in that regard.”

Women diagnosed with postpartum depression currently are treated with antidepressants and psychotherapy, but the drugs take four to eight weeks to be fully effective and generally have only a small-tomoderate impact. The new drug, by contrast, takes effect quickly and lasts at least 30 days, according to clinical studies.

Still, said Fiedorowicz, the cost and method of administration could prevent women from getting it.

Samantha Meltzer-Brody, a psychiatrist at the University of North Carolina, Chapel Hill, who led the clinical trials for the drug, said the medication is such an improvement over current therapies that she doubts the IV administration will discourage its use.