Zuranolone: The First FDA-Approved Oral Treatment Option for Postpartum Depression.

Abstract

Objective: The objective of this study was to review the characteristics, efficacy, and safety of zuranolone in the management of postpartum depression (PPD).

Data sources: Literature was identified using PubMed (1966-August 2023) and EMBASE (1973-August 2023) and clinicaltrials.gov. Search terms included zuranolone, SAGE-217, and PPD with further limitation of those published in English.

Study selection and data extraction: Articles selected for inclusion included trials evaluating zuranolone for the treatment of PPD.

Data synthesis: Zuranolone was evaluated for the treatment of moderate to severe PPD in 2 phase III trials. Both studies resulted in statistically significant improvement in depressive symptoms at day 15 (P = 0.003 and P < 0.001). Sustained differences in remission rates favoring zuranolone were found in both studies at day 45 compared with placebo (P = 0.01 and P < 0.05). Zuranolone was well tolerated, with somnolence, dizziness, headache, and sedation reported as the most common side effects.

Relevance to patient care and clinical practice in comparison to existing drugs: Zuranolone is only the second medication approved by the Food and Drug Administration (FDA) for PPD and offers an advantage over brexanolone in that it can administered orally in the outpatient setting. The rapid onset of effect of zuranolone is advantageous to traditional antidepressant therapy which can be weeks to months; however, limited information is available on safety during lactation.

Conclusions: The recent FDA approval of oral zuranolone for PPD offers a second rapid-acting treatment for PPD, extending the opportunity for treatment to patients in the outpatient setting.