Shots:

• The P-III (CORAL Study/217-MDD-305) evaluates the efficacy & safety of zuranolone (50mg) co-initiated with an SoC ADT vs SoC ADT + PBO in 440 adults with MDD
• The trial met its 1EPs & 2EPs i.e., reduction in depressive symptoms @3 Day & ~2wks., reduction in HAMD-17 score @ Days 8 & 12 while Day 15 showed numerical superiority & Day 42 showed equivalence, 180 (84.9%) received zuranolone + ADT & 177 (81.2%) received ADT + PBO, was well-tolerated with no new safety signals
• Additionally, no evidence of increased suicidal ideation/behavior, TEAEs leads to discontinuation (6.6% vs 3.7%). The company plans to start the rolling submission for NDA in MDD in 2022 with expected completion in H2’22

 Ref: Biogen | Image:Biogen