Sage : Phase 3 Study Of Zuranolone On Major Depressive Disorder Meets Primary & Secondary Endpoints

(RTTNews) - Sage Therapeutics Inc. (SAGE) and Biogen Inc. (BIIB) said that the phase 3 CORAL study in people with major depressive disorder met its primary and key secondary endpoints. The study compared Zuranolone 50 mg co-initiated with Standard of Care Antidepressant vs. Standard of Care Co-initiated with Placebo in People with major depressive disorder.

At the Day 3 primary endpoint, zuranolone 50 mg co-initiated with a standard of care antidepressant showed a statistically significant reduction in depressive symptoms.

The key secondary endpoint demonstrated zuranolone co-initiated with an antidepressant was statistically significant in reducing depressive symptoms compared to an antidepressant co-initiated with placebo over the 2-week treatment period.

Zuranolone 50 mg co-initiated with a standard of care antidepressant was generally well-tolerated with most treatment emergent adverse events reported as mild or moderate and no new safety signals identified.

The company said it remains on track to start the rolling submission for a New Drug Application in major depressive disorder early this year with completion targeted for the second half of 2022.