Sage and Biogen Announce Positive 1-year Data for Zuranolone in Major Depressive Disorder, NDA Filing Planned for 2022

Sage Therapeutics and Biogen announced 12-month data from the ongoing phase 3 SHORELINE study evaluating zuranolone in adult patients with major depressive disorder (MDD). The trial is an open-label, 1-year longitudinal study evaluating the safety, tolerability, and need for repeat dosing with zuranolone in adults with MDD. The study is comprised of multiple cohorts. This data addresses a cohort of patients (n=199), who received zuranolone 50 mg once nightly for 14-days as their initial dose in the ongoing SHORELINE Study and had the opportunity to be followed for 12-months. The data showed that 75% of patients responded to the initial 14-day course. Of those who responded to the first dosing course and continued in the study, about 80% received at most one additional zuranolone treatment during the year. Zuranolone was generally well-tolerated by patients regardless of the number of treatment courses received during the one-year study.

The SHORELINE Study is part of the LANDSCAPE clinical program. The trial comprises multiple cohorts, including a completed cohort with zuranolone 30 mg as a starting dose and an ongoing cohort with zuranolone 50 mg as a starting dose; both cohor...

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