(Reuters) - An advisory panel to the U.S. Food and Drug Administration on Friday recommended Sage Therapeutics Inc’s experimental treatment for postpartum depression, saying the benefits of the drug outweighed risks.
The panel voted 17-1 in favor of the injectable treatment, Zulresso, which aims to treat major episodes of depression during pregnancy or within four 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.
All members voted in favor of the treatment’s efficacy, while an overwhelming majority backed it on its safety.
The decision comes two days after FDA staff reviewers raised safety concerns over the loss of consciousness in certain patients who were on the treatment.
They, however, recommended implementing a risk evaluation and mitigation strategy (REMS) program to improve the safety of the product.
Panel member Steven Meisel said along with the REMS program, there is a need for a “black box” warning, the regulator’s strictest, highlighting the risk of patients hurting themselves or their babies due to loss of consciousness.
Zulresso, which is administered as a 60-hour intravenous infusion, targets hormonal changes in new mothers, differentiating it as a drug for postpartum depression rather than “regular” depression.
The FDA staffers on Wednesday 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, a severe form of “baby blues”, is a common complication of childbirth that affects one in nine women, according to the Centers for Disease Control and Prevention.
Existing treatments include a range of antidepressants, psychotherapy and even shock therapy that fall short of effectively addressing the disorder and have not been specifically approved for postpartum depression.
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.
Reporting by Saumya Sibi Joseph in Bengaluru; Editing by Shounak Dasgupta and Anil D’Silva
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