Los Angeles, March 20 (IANS) The US Food and Drug Administration (FDA) has approved a drug for the treatment of postpartum depression (PPD) in adult women.
The FDA on Tuesday approved intravenous infusion of the drug brexanolone, which will be sold as Zulresso. It is the first drug approved by the FDA specifically for PPD, Xinhua quoted a FDA release as saying.
Zulresso will be administered as a continuous IV infusion over 60 hours, according to the statement.
Patients will be counselled on the risks of the treatment and instructed to be monitored for the side effects at a health care facility for the entire duration of infusion.
PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. According to statistics, PPD impacts one in nine new mothers after childbirth.
“Postpartum depression is a serious condition that, when severe, can be life-threatening. It’s first time that a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” said Tiffany Farchione from the FDA.
Zulresso will be available to patients only through a restricted distribution programme at certified health care facilities. It is likely to be priced $20,000-35,000 per treatment, said Sage Therapeutics, the company that developed the drug.
The medication will be available in June.
–IANS
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