WASHINGTON — The FDA made history late Tuesday when it approved brexanolone (Zulresso), the first drug approved to specifically treat postpartum depression.
But due to concerns about risks, such as excessive sedation or loss of consciousness, the drug will only be administered with a Risk Evaluation and Management Strategy (REMS) that includes a “restricted distribution program.” This means the drug will be administered by a healthcare provider in a certified healthcare facility, where patients can be monitored after administration, the agency said in a statement.
“This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option,” added Tiffany Farchione, MD, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
Approval was based on two clinical studies of patients with severe or moderate postpartum depression, where brexanolone showed superiority to placebo, based on a mean change from baseline in depressive symptoms, the agency said. The drug was superior to placebo following the first infusion and an improvement in depression was also seen at the end of the 30 day follow-up period in the intervention group, the agency noted.
At an FDA advisory committee meeting in November, the group voted overwhelmingly to recommend approval of the drug, with committee members calling it an “exciting breakthrough” and saying it would be “one of the greatest approvals ever” since Prozac. But the agency clearly took the committee’s comments about safety into account, with concerns raised over six patients in the trials with observed loss of consciousness/pre-syncope.
In its statement, the FDA said that the Zulresso REMS program requires that patients be enrolled in the program prior to the administration of the drug, which will be administered as a continuous IV infusion over 60 hours. Patients will be required to have pulse oximetry monitoring, will be monitored for excessive sedation/loss of consciousness and must be “accompanied during interactions with their child(ren),” the agency said.