Zuranolone is an investigational two-week, once-daily oral drug being studied in postpartum depression and major depressive disorder. Samantha Meltzer-Brody, MD, MPH, Chair of the UNC Department of Psychiatry and Director of the UNC Center for Women’s Mood Disorders, is the principal investigator for the UNC Medical Center site of this study.
Postpartum depression (PPD) is one of the most common medical complications during and after pregnancy impacting approximately 1 in 8 women annually in the U.S. While recognized by the U.S. Department of Health and Human Services as a high-priority public health issue, screening rates vary and nearly 70% of women with PPD may go undiagnosed.
There is currently only one drug, ZULRESSO® (brexanolone) injection, approved by the U.S. Food and Drug Administration (FDA) specifically for treatment of PPD. ZULRESSO was developed by Sage Therapeutics, Inc. Sage and Biogen have now reported positive findings from the Phase 3 SKYLARK Study evaluating zuranolone, an investigational two-week oral drug, in women with PPD.
The Phase 3 SKYLARK Study of zuranolone met its primary and all key secondary endpoints. Women treated with zuranolone 50 mg (n=98) demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, compared to placebo (n=97) as measured by a change from baseline (CFB) in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score.
“This new data is exciting because it confirms and further supports the potential for zuranolone to be a rapidly acting and novel oral antidepressant in treating postpartum depression. If approved, zuranolone would be an important new tool for treating postpartum depression, which is desperately needed,” said UNC site principal investigator Samantha Meltzer-Brody, MD, MPH, Chair of the UNC Department of Psychiatry and Director of the UNC Center for Women’s Mood Disorders.
The study met all key secondary endpoints with rapid and statistically significant improvement in depressive symptoms as early as Day 3 for participants treated with zuranolone 50 mg compared to placebo, which was sustained at all measured timepoints through Day 45 as measured by CFB in HAMD-17 total score.