Sage and Biogen Present P-III (SKYLARK) Study Results of Zuranolone for Postpartum Depression at ECNP 2022
Shots:
- The P-III (SKYLARK) study evaluates zuranolone (50mg) vs PBO in 200 adult women with sev. PPD. The trial met the 1EPs & 2EPs i.e., rapid & significant improvements in depressive symptoms @Day 15/3/28/45
- In an additional 2EPs, a higher proportion of patients achieved a HAMD-17 response on Days 3/8/15/21/28 & HAMD-17 remission @Day 3 through Day 45, reduction in other PPD-related symptoms, improvement in symptoms of anxiety at Days 3/8/15/45, was well-tolerated with a consistent safety profile with that observed in the clinical development program
- The companies have initiated a rolling submission of zuranolone’s NDA to the US FDA for MDD and PPD with an expected completion of NDA filing in H2’22
Ref: Buisnesswire | Image: Biogen
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