Sage Therapeutics Announces FDA Approval of ZULRESSO (brexanolone) Injection, the First Treatment Specifically for Postpartum Depression

VCBeat (WeChat Official Account: vcbeat) has learned that on March 19, 2019, biopharmaceutical company Sage Therapeutics announced that the U.S. Food and Drug Administration (FDA) had approved its injectable drug ZULRESSO for the treatment of postpartum depression. Postpartum depression is the most common complication of childbirth, and ZULRESSO is the first and only medication specifically indicated for this condition. ZULRESSO is expected to become available in the U.S. market by late June, with the FDA aiming to facilitate its launch within 90 days.

“The FDA’s approval of ZULRESSO represents a major breakthrough in the medical treatment of postpartum depression,” said Samantha Meltzer-Brody, MD, the Ray M. Hayworth Distinguished Professor of Psychiatry and Director of the Perinatal Psychiatry Program, as well as the Principal Investigator for the ZULRESSO clinical trials at the Center for Women’s Mood Disorders at the University of North Carolina. “The advent of ZULRESSO marks an exciting milestone in the history of treating women’s mental health. Postpartum depression is recognized to have significant and long-lasting impacts on women and their families, and ZULRESSO provides us with an opportunity to change this.”

Postpartum depression can affect women during pregnancy or after childbirth. It is estimated that in the United States, one in nine women who have given birth is affected by postpartum depression. Symptoms of postpartum depression include sadness, anxiety, irritability, withdrawal from friends or family, difficulty bonding with the baby, and thoughts of harming oneself or even the child. Furthermore, without proper screening, up to half of postpartum depression cases may go undiagnosed.

The ZULRESSO research program is on the U.S. Food and Drug Administration’s (FDA) Priority Review list. Priority Review is designated for investigational therapies that, if approved, could represent a significant advance in the treatment, prevention, or diagnosis of serious conditions. As early as 2016, ZULRESSO was granted Breakthrough Therapy designation, reflecting broad recognition of its importance and underscoring the severe and non-negligible prevalence of postpartum depression.

Jeff Jonas, M.D., Chief Executive Officer of Sage Therapeutics, said, “We are proud to have played a part in and witnessed this pivotal moment in mental health, which has created an opportunity to transform how postpartum depression is perceived and treated. We thank the patients, researchers, healthcare providers, advocates, caregivers, and Sage Therapeutics employees who collectively ensured the approval of the first medication specifically indicated for the treatment of postpartum depression. We believe that ZULRESSO will address women’s mental health needs, and we look forward to bringing ZULRESSO to patients in urgent need of new treatment options. ZULRESSO will heighten awareness of women’s mental health and underscore the importance of diagnosing and treating postpartum depression.”

In controlled trials across various drug dosages, the ZULRESSO group demonstrated significant efficacy compared with the placebo group. Patients experienced relief from depressive symptoms as early as 24 hours. By 60 hours, the total score on the Hamilton Depression Rating Scale (a commonly used measure of depression severity) was significantly reduced from baseline in the ZULRESSO group. Moreover, favorable outcomes were maintained throughout the 30-day follow-up period. The most common adverse effects observed in the study were somnolence, dry mouth, flushing, and distractibility.

Postpartum depression is a form of depression unique to women that can occur during pregnancy or after childbirth, making it the most common complication of delivery. Medical experts vary in their opinions regarding the onset of postpartum depression, with cases potentially arising anytime from the gestational period up to 12 months postpartum. Postpartum depression can have devastating consequences for women and their families, including severe functional impairment, depressed mood, and loss of interest in the newborn, as well as other symptoms associated with depression such as loss of appetite, sleep difficulties, psychomotor disturbances, difficulty concentrating, loss of energy, and low self-esteem. Suicide is the leading cause of death among patients with postpartum depression. In the United States, 400,000 women suffer from postpartum depression each year, a figure that likely excludes cases missed due to inadequate screening.

SAGE Therapeutics, founded in 2010, is a clinical-stage biopharmaceutical company dedicated to developing novel therapies that transform the lives of patients with central nervous system (CNS) disorders. SAGE Therapeutics is advancing a pipeline of new candidate products targeting key CNS conditions, including Sage-217, which is currently in Phase 3 development for major depressive disorder and postpartum depression. The mission of SAGE Therapeutics is to develop innovative treatments for some of today’s most pressing CNS diseases by leveraging its cutting-edge scientific technology, robust clinical foundation, strong strategic partnerships, and a world-class team comprising founders, advisors, investors, scientists, and executives.

(Compiled by Wang Shuijing)