Sage's Postpartum Depression Treatment Benefits Outweigh Risk: FDA Panel
By Saumya Joseph
The benefits of Sage Therapeutics Inc's experimental treatment for postpartum depression outweigh risks, an advisory panel to the U.S. Food and Drug Administration said on Friday.
The panel voted 17 to 1 in favor of the injectable treatment, Zulresso, that aims to treat major episodes of depression during pregnancy or within 4 weeks of delivery.
"I believe that (Zulresso) may be a game changer in the treatment of postpartum depression. This is what hope looks like," said Felipe Jain, a panel member.
The decision comes two days after FDA staff reviewers raised safety concerns about the loss of consciousness, which was experienced by certain patients.
The FDA staffers also said Zulresso may not yet be suitable for use at home without supervision by a physician, and patients should be constantly monitored for signs of dizziness while under treatment.
Postpartum depression is a common complication of childbirth that affects 1 in 9 women, according to the Centers for Disease Control and Prevention.
The FDA, expected to announce its final decision on the treatment by Dec. 19, is not mandated to follow the recommendation of the panel, but generally does.
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