First FDA Approved Postpartum Depression Drug



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

Zulresso, created by Sage Therapeutics, is an intravenous drug administered "as a continuous infusion" for 60 hours, or two and a half days, the agency said in a press release.

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In a company-funded study of new mothers with moderate or severe postpartum depression, half of women treated with Zulresso would suffer from depression after two and a half days, about twice the rate of those in the group. witness receiving false treatments.

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

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

Excessive crying, overwhelming fatigue, difficulty in bonding with the newborn, fear of being an inadequate mother or total hopelessness are symptoms associated with postpartum depression which, according to medical authorities, may develop in the first few years. weeks after childbirth, but can start earlier or later.

It affects about 400,000 American women a year and can be treated with antidepressants. It takes between six and eight weeks to work and not help everyone, nor with advice.

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"Postpartum depression is a serious condition that, when it is serious, can be life-threatening, and women may have ideas to harm themselves or their child," said Dr. Tiffany Farchione, MD. FDA's Division of Psychiatric Products, in the press release.

Farchione added that "postpartum depression can also interfere with the bond between mother and baby." This approval marks the first time that a drug is specifically approved to treat postpartum depression, thus offering a new important treatment option. "

The active ingredient in Zulresso, brexanolone, mimics a derivative of progesterone, a natural hormone, whose levels may drop after childbirth. Dr. Jeff Jnas, CEO of Sage, says the infusion helps restore normal levels and emotions.

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Sage said that Zulresso would cost $ 34,000 without insurance, plus the cost of hospital stay or an infusion center. The treatment covered by the insurance is determined by each insurance company, which also determines the reimbursable expenses, depending on the plan.

The company – which is developing a similar pill-like treatment – plans to start selling the drug at the end of June.

Associated Press contributed to this report.

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