FDA OKS drug to treat severe postpartum depression

TRENTON, N.J. — The U.S. Food and Drug Administration has approved the first drug specifically developed for severe depression after childbirth.

The agency on Tuesday approved Sage Therapeutics’ Zulresso, an IV drug given over 2½ days.

Sage said Zulresso will cost

$34,000 without insurance, plus costs for staying in a hospital or infusion center. Whether the treatment gets covered by insurance is determined by each insurance company, which also sets the out-of-pocket costs, depending on the plan.

In a company-funded study of new mothers with moderate or severe postpartum depression, half the women given Zulresso had depression end within 2½ days, about double the rate of those in a comparison group given dummy treatments.

Postpartum depression affects about 400,000 American women a year. It often ends on its own within a couple weeks, but it can continue for months or even years. It can be treated with antidepressants or with counseling.

“Postpartum depression is a serious condition that, when severe, can be life-threatening,” Dr. Tiffany Farchione of the FDA’S Division of Psychiatry Products said in a statement. “Women may experience thoughts about harming themselves or harming their child.”

The drug’s most common side effects were sleepiness, dizziness and headaches. A few women had more-serious problems, such as fainting and loss of consciousness.

Because those risks could result in injury, the FDA said it is restricting Zulresso’s use to certified health care facilities where patients can be closely monitored throughout the infusion.

Zulresso appears safe for breastfeeding, said Dr. Kimberly Yonkers, a psychiatrist specializing in postpartum depression who heads Yale Medical School’s Center for Wellbeing of Women and Mothers.

She expects the drug will be used to treat serious cases and patients not helped by antidepressants.

Sage plans to begin selling the drug in late June.