Zuranolone: A Narrative Review of a New Oral Treatment for Postpartum Depression

Abstract

PurposePostpartum depression is a prevalent and overlooked mental disorder. Pathophysiology is thought to originate from a combination of biological and social factors, including hormones, and genetics. The consequences of untreated postpartum depression can be severe and negatively impact maternal and infant health. Zuranolone was approved as an oral agent in August 2023 for the treatment of postpartum depression in adults. The purpose of this article is evaluating the clinical aspects of zuranolone, including safety and efficacy pertaining to the drug and the clinical data that led to its approval. MethodsA literature search was conducted using PubMed, Web of Science, and EMBASE with the terms postpartum depression, postpartum depression management, and zuranolone to locate relevant data for this narrative review. The prescribing information of zuranolone and clinicaltrials.gov were also utilized. FindingsTwo Phase III trials (Study 1-NCT04442503 and Study 2-NCT02978326) led to the approval of zuranolone by the Food and Drug Administration (FDA) based on clinically meaningful improvement in depressive symptoms. The trials met their primary endpoint, a change from baseline in HAM-D total score at day 15 (Study 1; 95% CI −6.3 to −1.7, P = 0.001: Study 2; 95% CI (−6.9 to −1.5, P = 0.003). ImplicationsZuranolone, an oral and rapidly acting antidepressant, represents a promising new oral treatment option for individuals with postpartum depression.