WEDNESDAY, March 20, 2019 (HealthDay News) — Zulresso (brexanolone) injection has been approved for intravenous (IV) use in the treatment of postpartum depression (PPD) in adult women, marking the first drug approved specifically for PPD, the U.S. Food and Drug Administration announced yesterday.
The drug is administered as a continuous IV infusion during a period of 60 hours and will only be available through the restricted Zulresso Risk Evaluation and Mitigation Strategy Program, which requires it is administered by a health care provider in a certified health care facility. The Boxed Warning information indicates that Zulresso carries a risk for sudden loss of consciousness; therefore, patients must be monitored for excessive sedation and sudden loss of consciousness and require continuous pulse oximetry monitoring. Patients must enroll in the program before drug administration and will be counseled on the risks accompanying Zulresso.
Zulresso’s approval was based on efficacy data from two clinical studies of patients with severe PPD and moderate PPD who received a 60-hour continuous IV infusion of Zulresso or placebo. Patients were followed for four weeks. In both studies, researchers found that Zulresso was superior to placebo in improvement in depressive symptoms as measured by a depression rating scale at the end of the first infusion and at the end of the 30-day follow-up period.
During infusion treatment, patients must be accompanied when interacting with their children. They must not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from Zulresso have subsided. The most commonly reported adverse reactions with Zulresso include sleepiness, dry mouth, loss of consciousness, and flushing. The FDA recommends that health care providers consider changing the therapeutic regimen — including discontinuing Zulresso if necessary — in patients whose PPD becomes worse and in those who experience suicidal thoughts and behaviors.
Approval of Zulresso was granted to Sage Therapeutics.
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