Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data

Abstract

Background: Brexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years. Brexanolone is available commercially only through a restricted program (ZULRESSO® Risk Evaluation and Mitigation Strategy; REMS) due to risk of excessive sedation or sudden loss of consciousness during administration. Objective: The aim of this analysis was to assess the postmarketing safety of brexanolone in adults with PPD. Methods: The cumulative postmarketing adverse event (AE) listing from spontaneous and solicited individual case safety reports (ICSRs) received from March 19, 2019, through December 18, 2021, was analyzed. Clinical trial ICSRs were excluded. Reported AEs were classified as serious or nonserious as defined by FDA seriousness criteria and as listed or unlisted based on Table 2.0 within section 6 “Adverse Reactions” of the current brexanolone FDA-approved US Prescribing Information (PI). Results: Overall, 499 patients received brexanolone in this postmarketing surveillance analysis between June 2019 and December 2021 (postmarketing setting). There were 137 ICSRs with 396 total AEs: 15 serious unlisted, 2 serious listed, 346 nonserious unlisted, and 33 nonserious listed. In total, two serious and one nonserious listed excessive sedation AEs were reported—all resolved by stopping infusion and did not require any treatment; no loss of consciousness AEs were received. Conclusion: Results from postmarketing surveillance data analysis are consistent with the safety profile of brexanolone for the treatment of PPD as described in the FDA-approved PI. No new safety concerns or new aspects of known risks requiring an update to the FDA-approved PI were identified.