FDA approves drug for postpartum depression

The Food and Drug Administration (FDA) announced Tuesday that it has approved the first drug specifically designed to treat postpartum depression.

The drug, brexanolone, will be marketed as Zulresso. The drug will be available to women through a program called Zulresso REMS, which will require the drug to be administered by a doctor in a certified health-care facility, the FDA said.

{mosads}Postpartum depression is a major depressive episode occurring after childbirth that affects thousands of women each year.

Tiffany Farchione, the acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, called Zulresso “an important new treatment option.”

“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,” Farchione said in a statement.

The FDA noted that postpartum depression is characterized by symptoms including sadness, loss of interest in activities, feelings of worthlessness or guilty and suicidal ideation, among others.

Zulresso’s manufacturer, Sage Therapeutics, has said a course of treatment for the drug would likely cost between $20,000 and $35,000.