First Postpartum Depression Drug Has Severe Restrictions
FDA imposed its most restrictive distribution program on the nation’s first postpartum depression (PPD) drug for adult women, Sage Therapeutics’ intravenous Zulresso (brexanolone). The severe restrictions in its Risk Evaluation and Mitigation Strategy (REMS) is due to concerns about serious risks, including excessive sedation or sudden loss of consciousness during administration. Under the REMS, Zulresso will only be available at certified health care facilities where the health care provider can carefully monitor the patient.
The REMS mandates that patients be enrolled in the program prior to administration of the drug. It has to be administered as a continuous 60-hour (2.5 days) IV infusion. “Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood),” FDA says. “While receiving the infusion, patients must be accompanied during interactions with their child(ren).” Patients are also warned not to drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away.
Approval was based on data from two clinical studies in participants who received a 60-hour continuous intravenous infusion of Zulresso or placebo and were then followed for four weeks. The primary endpoint was the mean change from baseline in depressive symptoms as measured by a depression rating scale, FDA says. “In both placebo‑controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion,” it says.
The approval also follows the backing of an 11/2018 advisory committee meeting, which voted 17 to 1 that data supported the drug’s benefit-risk profile. Panel members recommended that the drug be administered by qualified staff in a facility that has been certified under the REMS program (see earlier story).
Panel member and University of Iowa psychiatrist Jess Fiedorowicz told the Washington Post that the $30,000-plus cost and method of administration could prevent women from getting the therapy. Anna Glezer, a psychiatrist at the University of California at San Francisco, told the Post that she was encouraged to see an entirely new approach to medication for depression. Due to its restrictive administration, Glezer said she expects it to be used mainly in the most severe cases, especially women whose postpartum depression requires hospitalization.