First postpartum depression drug for women approved in U.S.

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Today's Global News Hour at 6 Health Matters is brought to you by Pharmasave. Doctors say an experimental drug for postpartum depression is having such positive results it could become the first treatment approved for the condition – Sep 8, 2018

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 two-and-a-half days.

Sage said Zulresso will cost US$34,000 without insurance, plus costs for staying in a hospital or infusion centre. 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 two-and-a-half days, about double the rate of those in a comparison group given dummy treatments.

READ MORE: Postpartum depression symptoms worse during the holidays

Postpartum depression affects about 400,000 American women a year. It often ends on its own within a couple of weeks, but it can continue for months or even years. It can be treated with antidepressants, which can take six to eight weeks to work and don’t help everyone, or with counselling.

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

Zulresso’s active ingredient, brexanolone, mimics a derivative of the naturally occurring hormone progesterone, levels of which can plunge after childbirth. The infusion helps restore normal levels and emotions, according to Sage chief executive Dr. Jeff Jonas.

READ MORE: How hired postpartum help is becoming more commonplace for moms

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.

READ MORE: Mom shares gripping photo of what postpartum depression looks like

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.

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“It’s going to depend on patient willingness to go into an infusion centre and insurers being willing to pay for this,” Yonkers added.

Sage plans to begin selling the drug in late June.

It’s developing a second, similar treatment in pill form, and Marinus Pharmaceuticals is testing both a pill and IV therapy.

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