Sage and Biogen Report Results of Zuranolone in P-III WATERFALL Study for Major Depressive Disorder

June 15, 2021 Auto Bot Biogen, Clinical Trials, P-III, Zuranolone 0

Shots:

  • The P-III WATERFALL study involves assessing the efficacy and safety of zuranolone (50mg, once-nightly for 2wks.) in 543 adults aged 18-64yrs. with MDD with a HAMD-17 total score ≥24 at screening and day 1 prior to dosing
  • The study met its 1EPs demonstrating improvement in depressive symptoms @day15 as assessed by the HAMD-17 total score (-14.1 vs -12.3); mean SD baseline HAMD-17 score at entry into the study (26.8 vs 26.9); TEAEs (60.1% vs 44.6%)
  • Zuranolone is an investigational oral NAS GABA-A receptor PAM and has received BTD from the US FDA. The therapy is currently being evaluated as a potential rapid-acting, 2wks. treatment for PPD and MDD in the NEST and LANDSCAPE studies

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