The U.S. Food and Drug Administration (FDA) has approved the zuranolone (ZURZUVAE, Sage Therapeutics, Inc. and Biogen Inc.) 50 mg for adults with postpartum depression (PPD). Zuranolone is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD.

The Postpartum depression (PPD) approval is based on results from two Phase 3 clinical trials, ROBIN and SKYLARK. Both studies met their primary endpoint, a significant mean reduction from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score, a common measure of depression severity, at Day 15 as compared to placebo.

In the SKYLARK Study evaluating zuranolone 50 mg, all key secondary endpoints were met, with significant reduction in depressive symptoms seen as early as Day 3 and sustained through Day 45. Zuranolone was generally well-tolerated with a consistent safety profile across both studies. The most common side effects (>5% and greater than placebo) in patients treated with zuranolone 50 mg were somnolence, dizziness, diarrhea, fatigue and urinary tract infection.

Additionally, the FDA issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for zuranolone in the treatment of adults with major depressive disorder (MDD). The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that an additional study or studies will be needed. Sage and Biogen are reviewing the feedback and evaluating next steps.

>>  Sage Therapeutics, Inc. and Biogen Inc. Press Release

Reference:

Deligiannidis KM et al. AJP. Epub ahead of print. Abstract