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The US Food and Drug Administration has approved the first drug specifically developed for the treatment of severe depression after childbirth.
The agency on Tuesday approved Zulresso's Sage Therapeutics, an intravenous drug administered for 2 and a half days.
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.
In a company-funded study of new mothers with moderate or severe postpartum depression, half of women treated with Zulresso experienced depression after 2.5 days, about twice the rate in control group under dummy treatment.
Postpartum depression affects about 400,000 American women a year. It often ends in a few weeks, but it can last for months or even years. He can be treated with antidepressants, which can take six to eight weeks to work and do not help everyone, or with counseling.
"Postpartum depression is a serious condition that, when it is serious, can be life-threatening," said Dr. Tiffany Farchione of the FDA's Division of Psychiatric Products in a statement. "Women may have the idea of hurting themselves or their child"
The active ingredient in Zulresso, brexanolone, mimics a derivative of progesterone, a natural hormone, whose levels may drop after childbirth. The infusion helps restore normal levels and normal emotions, according to Dr. Jeff Jonas, general manager of Sage.
The most common side effects of the drug were drowsiness, dizziness and headache. Some women had more serious problems, such as fainting and loss of consciousness.
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As these risks could result in injury, the FDA has stated that it limits the use of Zulresso to licensed health facilities, where patients can be closely monitored throughout the infusion.
Zulresso seems safe for badfeeding, said Dr. Kimberly Yonkers, a psychiatrist specializing in postpartum depression and head of the Center for the Welfare of Women and Mothers at Yale Medical School.
She expects the drug to be used to treat serious cases and patients not helped by antidepressants.
"It will depend on the patient's willingness to visit an infusion center and the insurers' willingness to pay for it," added Yonkers.
Sage plans to start selling the drug in late June.
He is developing a second similar pill treatment and Marinus Pharmaceuticals is testing both pill therapy and intravenous therapy.
Mother holding her newborn baby after work in the hospital.
Getty Images / iStockphoto
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