Brexanolone, first drug to treat postpartum depressionMay 8, 2019
Brexanolone (Zulresso) injection has been granted approval by US FDA for use in the treatment of postpartum depression (PPD) in adult women.
This is the first drug approved by the FDA specifically for PPD, the agency said.
Brexanolone has been given clearance with a Risk Evaluation and Mitigation Strategy (REMS) and is only available to patients through a restricted distribution programme at certified health care facilities where the health care provider can carefully monitor the patient.
The drug is administered as a continuous IV infusion over a total of 60 hours (2.5 days). 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. While receiving the infusion, patients must be accompanied during interactions with their child(ren). The need for these steps is addressed in a Boxed Warning in the drug’s prescribing information.
The efficacy of brexanolone was shown in two clinical studies in participants who received a 60-hour continuous intravenous infusion of the drug or placebo and were then followed for four weeks. One study included patients with severe PPD and the other included patients with moderate PPD. The improvement in depression was also observed at the end of the 30-day follow-up period.