For the first time in history, the US Food and Drug Administration has approved a drug specifically indicated for the treatment of postpartum depression, a mental illness that affects about one in nine mothers after childbirth, according to the Centers for Disease Control and Prevention.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond,” said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option.”
The drug will be known as Zulresso, given in an IV over a three-day period in the hospital. It rebalances hormones that spike during pregnancy and plummet after birth. Unlike conventional antidepressants, the effect can be almost immediate.
The drug works very quickly, within 48 hours — a significant improvement over currently available antidepressants, which can take two to four weeks to have an effect, if they work at all.
“Because of concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration, Zulresso has been approved with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution program at certified health care facilities where the health care provider can carefully monitor the patient.”
The infusion will be expensive, averaging $34,000 per patient before discounts, according to Sage Therapeutics, the manufacturer. That does not include the costs of staying in a medical center for two and a half days. Company officials say they expect that insurers will cover the treatment; insurers said this week that they are evaluating the drug.
Researchers stress women need to be screened and discuss all treatment options. This drug, which should be available by June, will be an option for treating women very quickly and that’s important because the first few weeks of life are such a critical time for mother and baby.
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