First drug targeting postpartum depression approved by FDA

The first-ever drug created specifically to combat postpartum depression was approved by the U.S. Food and Drug Administration (FDA) on Tuesday.

Zulresso, created by Sage Therapeutics, is an IV drug administered “as a continuous infusion” over the course of 60 hours, or two and a half days, the agency announced in a news release.

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

Getting the “baby blues” after childbirth is common, according to the Mayo Clinic. After childbirth, “most” new mothers experience a range of symptoms, including mood swings, crying, trouble sleeping and irritability.

But some other mothers experience stronger, more severe emotions that are considered postpartum depression.

Excessive crying, overwhelming fatigue, difficulty bonding with the newborn child, fear of being an inadequate mother or total hopelessness are symptoms connected to postpartum depression that medical officials say can develop within the first few weeks following childbirth, but can start earlier or later.

It affects around 400,000 American women a year and can be treated with antidepressants, which can take six to eight weeks to work and don’t help everyone, or with counseling.

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

Farchione added that, “Postpartum depression can also interfere with the maternal-infant bond. This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”

Zulresso’s active ingredient, brexanolone, mimics a derivative of the naturally occurring hormone progesterone, levels of which can plunge after childbirth. Sage Chief Executive Dr. Jeff Jnas says the infusion helps restore normal levels and emotions.

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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.

The company — which is developing a similar treatment in pill form — plans to begin selling the drug in late June.

The Associated Press contributed to this report.

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