On March 19, 2019 the U.S. Food and Drug Administration approved Zulresso (brexanolone) intravenous (IV) formulation for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the USFDA specifically for PPD17.
The approval of Zulresso was based on two placebo controlled clinical efficacy studies on participants with severe to moderate PPD, where participants received a 60-hour continuous intravenous infusion of Zulresso or placebo and were then followed for four weeks. The studies primary measure in the study was the mean changes in depressive symptoms using depression rating scale. In both placebo controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period Zulresso will be available through a restricted distribution program only at certified health care facilities for Risk Evaluation and Mitigation Strategy (REMS), where the health care provider can carefully monitor the patient for drug safety and efficacy.
The approval of Zulresso was granted to Sage Therapeutics, Inc. The FDA granted this application Priority Review and Breakthrough Therapy designation.
About postpartum depression
PPD is a major depressive episode that occurs following childbirth, although symptoms can start during pregnancy. As with other forms of depression, it is characterized by sadness and/or loss of interest in activities that one used to enjoy and a decreased ability to feel pleasure (anhedonia) and may present with symptoms such as cognitive impairment, feelings of worthlessness or guilt, or suicidal ideation.
About ZULRESSO"
ZULRESSO, the first medicine specifically approved by the U.S. Food and Drug Administration for the treatment of postpartum depression, is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. Allosteric modulation of neurotransmitter receptor activity results in varying degrees of desired activity rather than complete activation or inhibition of the receptor18.
About REMS
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication. While all medications have labeling that informs health care stakeholders about medication risks, only a few medications require a REMS.
Note - ZULRESSO is approved by the FDA for the treatment of PPD in adults, pending DEA scheduling. ZULRESSO has been granted PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA).
Footnotes
17 https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm633919.htm
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