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) for treatment of PPD. Sage Therapeutics, Inc., the developer of Zulresso, reports positive findings from their Phase 3 SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with PPD.
Sage Therapeutics and Biogen Inc. have announced that 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 HAMD-17 total score.
"This new data is exciting because it confirms and further supports the efficacy of zuranolone, a rapidly acting and novel oral antidepressant, in treating postpartum depression. It 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.
Read the entire press release from Sage.
