(#34) Efficacy of Olanzapine Extended-Release Injectable Suspension (TV-44749) for Subcutaneous Use Demonstrated in Patients With Schizophrenia: Results From a Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial (SOLARIS)

Abstract: TV-44749 is a once-monthly, subcutaneous, extended-release injectable based on innovative copolymer delivery technology that ensures controlled release of olanzapine, designed to provide sustained efficacy over 1 month without post-injection delirium/sedation syndrome (PDSS) risk. The Subcutaneous OLAnzapine extended-Release Injection Study (SOLARIS, NCT05693935) is a phase 3, multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study with an 8-week acute treatment phase (Period 1) and an open-label, long-term safety phase (Period 2) of TV-44749 in adults with schizophrenia. Here, we report the primary efficacy results from Period 1. A total of 675 (169 to each TV-44749 arm and 168 to placebo) adult patients with acute exacerbation of schizophrenia were randomized 1:1:1:1 to once-monthly TV-44749 (318mg, 425mg, or 531mg) or placebo. Mean (SD) age was 44.6 (11.7) years; 75% (n=381) were men and 67% (n=341) were Black. The primary endpoint was met; all three TV-44749 doses resulted in significantly greater change (95% confidence interval [CI]) from baseline to week 8 in Positive and Negative Syndrome Scale total score versus placebo (318mg: -9.75 [-13.60,-5.89]; 425mg: -11.27 [-15.01,-7.53]; 531mg: -9.76 [-13.50,-6.02]; all p