FDA Accepts NDA for Zuranolone for Depression

The FDA has accepted the new drug application (NDA) for zuranolone in to treat patients with major depressive disorder and postpartum depression. The application has been granted priority review and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of Aug. 5, 2023.

Developed by Sage Therapeutics and Biogen, zuranolone is a rapid-acting neuroactive steroid. In people with depression, it is thought to work by rapidly rebalancing dysregulated neuronal networks to help reset brain function. Zuranolone targets brain networks responsible for functions such as mood, arousal, behavior, and cognition.

It is estimated that more than 21 million adults in the United States experienced at least one major depressive episode in 2020, with nearly 14 million people diagnosed with major depressive disorder, and an estimated 500,000 cases of postpartum depression annually.

Laura Gault, M.D., Ph.D.

“Most current approved therapies may take weeks or months to work. We are committed to advancing treatments that could help physicians and patients by addressing depression symptoms quickly,” Laura Gault, M.D., Ph.D., chief medical officer at Sage said in a press release.

The zuranolone NDA includes data from the LANDSCAPE and NEST clinical development programs. The LANDSCAPE program includes five studies of zuranolone in adults with major depressive disorder (MDD-201B, MOUNTAIN, SHORELINE, WATERFALL, and CORAL). Data from the SHORELINE study were presented in at the 2022 Psych Congress in New Orleans in September 2022. An analysis from the ongoing open-label study found the median time to the first repeat treatment course for those patients who responded to the initial 14-day treatment course was 135 days for the completed 30 mg cohort and 249 days for the ongoing 50 mg cohort

The NEST program includes two studies of zuranolone in adult women with postpartum depression (ROBIN and SKYLARK). Data from SKYLARK were presented in October 2022 at the European College of Neuropsychopharmacology Congress. In the study, zuranolone met all primary and all key secondary endpoints, with study participants demonstrating rapid and significant improvements in depressive symptoms as early as day 3 that were sustained through day 45. Zuranolone was generally well-tolerated, with a safety profile consistent with previous clinical trials; most treatment-emergent adverse events (TEAEs) were mild or moderate in severity