Why drug for postpartum depression could be a 'game-changer'

The drug named Zulresso needs to be administered intravenously in a hospital over the course of 60 hours. — AFP  File

The U.S. Food and Drug Administration announced Tuesday the approval of the first drug specifically created to treat postpartum depression in new mothers.

But it needs to be administered intravenously in a hospital over the course of 60 hours because of the risk of fainting that was observed in some women during clinical tests.

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U.S. media say the treatment will cost $34,000 a year for people without health insurance.

"Postpartum depression is a serious condition that, when severe, can be life-threatening".

Although the new drug reportedly has no long-term negative side effects, it's not approved for women who are breastfeeding and is a sucker punch to the wallet.

"This brings up a lot of very complex public health issues", Dr. Kimberly Yonkers, a professor of psychiatry, obstetrics, gynecology and preproductive sciences at Yale, told the New York Times. But Zulresso's manufacturer, Sage Therapeutics, expects the drug to be covered under insurance. "Women may experience thoughts about harming themselves or harming their child, as well as hinder development of a maternal-infant bond", the press release reads.

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A pill form of the drug is now going through clinical trials, which would make Zulresso more widely available to patients unable to be admitted for an extended inpatient treatment as required when taken in the IV form.

Postpartum depression can start during pregnancy or at any time up to a year after the baby is born.

CEO Jeff Jonas says, "We are grateful for the patients, researchers, healthcare providers, advocates, caregivers and Sage employees who helped secure the approval of the first medicine specifically for postpartum depression". The treatment will be offered only as an in-patient option at certified medical centers because it can cause sudden loss of consciousness, according to an F.D.A.

Sage Therapeutics said the medication will be available in late June in the US.

"Women who had not wanted to eat or interact with others suddenly were smiling, interacting, becoming more social", Dr. Samantha Meltzer-Brody, director of the perinatal psychiatry program at the University of North Carolina's Center for Women's Mood Disorders, told CTV News.

"We have had the same treatments for depression for 30 years".

She called the FDA's approval "the beginning of the story" and said more studies will be done to understand exactly how Zulresso works in different women. "There's an enormous need for new, novel ways to treat depression, and to treat it quickly", she said. The pill, now known as SAGE-217, is produced from a comparable molecule to the particle used in Zulresso, the Times said. "What's heartbreaking is the number of women who suffer in silence and do not get the treatment that they need".

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