March 20 (UPI) -- U.S. regulators have approved the first medication designed specifically for women with postpartum depression, which the drug maker calls a breakthrough treatment.
The Food and Drug Administration approved Zulresso (brexanolone) on Tuesday for intravenous injection and to be administered through a restricted program, the agency said in a statement.
Postpartum depression is a major depressive episode for women that happens after childbirth -- although initial symptoms can start during pregnancy. It's characterized by sadness, loss of interest in activities that may lead to cognitive impairment and suicidal impulses.
"Women may experience thoughts about harming themselves or harming their child. Postpartum depression can also interfere with the maternal-infant bond," said Dr. Tiffany Farchione of the FDA 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."
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Farchione said Zulresso must be managed due to the risk of excessive sedation and sudden loss of consciousness.
The new treatment is costly -- averaging $34,000 per patient. The cost doesn't include hospital costs, since a medical facility is required to dispense the drug over a 60-hour period. The drug's relief lasts for about a month, Sage Therapeutics, the drug's manufacturer, said.
Sage called the new drug a "game-changing approach" to treating postpartum depression.
"This brings up a lot of very complex public health issues," Dr. Kimberly Yonkers, a professor of psychiatry, obstetrics, gynecology and reproductive sciences at Yale, told The New York Times.
"It may be worth it, if somebody has been treatment-resistant or they can't wait the two to four weeks for an antidepressant to kick in. Depression can be pretty miserable."
