FDA approves first drug for postpartum depression

The first drug specifically targeted at treating postpartum depression in new mothers has been approved, the Food and Drug Administration announced Tuesday.

Brexanolone, sold as Zulresso, is delivered as a continuous intravenous infusion over the course of 60 hours, the FDA said. The New York Times reported the drug works quickly – within two days – and costs $20,000 or more.

“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child,” said Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.

The Centers for Disease Control and Prevention estimated that postpartum depression affects one in nine women nationally.

Postpartum depression is treated with counseling and medication that can take weeks to work, the National Institute of Mental Health said.

Untreated postpartum depression can last for months or years, the institute said.

Zulresso will be available only from certified health care facilities through a restricted program called the “Zulresso REMS Program,” the FDA said.

Jeff Jonas, CEO of Sage Therapeutics, the company that developed Zulresso, told CNN the drug will be available in June.

The FDA said it approved Zulresso after two clinical studies demonstrated that the medicine outperformed a placebo at improving symptoms of depression over 30 days.

Those studies were sponsored by Sage, which is working to offer a pill version of the treatment, The Times reported.