Poster
85
(#85) Efficacy of Xanomeline and Trospium Chloride Across Symptom Domains in Adults With Schizophrenia: Pooled Analysis of Data From the Phase 3 EMERGENT-2 and EMERGENT-3 Clinical Trials
Psych Congress 2025
Abstract: Background: Xanomeline and trospium chloride (X/T) demonstrated significant improvement in PANSS total score compared with placebo in the pivotal EMERGENT-2 (NCT04659161) and EMERGENT-3 (NCT04738123) phase 3 trials. Post hoc analysis assessed efficacy across symptom domains in pooled data from these trials.
Methods: EMERGENT-2 and EMERGENT-3 were 5-week, randomized, double-blind, placebo-controlled trials in adults with schizophrenia experiencing acute psychosis, PANSS total score ≥80, and CGI-S score ≥4. Subjects were randomized 1:1 to receive X/T or placebo for 5 weeks. Efficacy analyses of the pooled modified intention-to-treat population included change from baseline to week 5 in PANSS total, PANSS Marder 5-factor, and individual PANSS items scores.
Results: Baseline characteristics were similar in X/T (n=231) and placebo (n=239) groups. X/T was associated with larger reductions in PANSS total score from baseline to week 5 compared with placebo (least squares mean difference [LSD]= - 9.2, P 0.0001, Cohen's d=0.59). Improvements with X/T compared with placebo persisted across PANSS Marder positive (LSD= -2.8), negative (LSD= -1.6), uncontrolled hostility (LSD= -1.4), disorganized thought (LSD= -1.9), and depression/anxiety (LSD= -1.5) factors (P 0.001 for all). The individual items that make up each Marder factor showed greater improvement with X/T compared with placebo, except for difficulty in abstract thinking, a component of the PANSS Marder negative subscale, in which score change from baseline was equivalent in both treatment groups.
Conclusion: In data pooled from the pivotal EMERGENT-2 and EMERGENT-3 trials, X/T demonstrated a consistent benefit across symptom domains among adults with schizophrenia as assessed by PANSS Marder 5-factor analysis.
Short Description: The poster presents data of pooled post hoc efficacy analyses of the phase 3 randomized, double-blind, placebo-controlled EMERGENT-2 and EMERGENT-3 trials of xanomeline and trospium chloride (X/T) vs placebo in adults with schizophrenia. The results showed a consistent benefit of X/T across symptoms of schizophrenia as assessed using PANSS Marder positive, negative, uncontrolled hostility, disorganized thought, and depression/anxiety factors.
Name of Sponsoring Organization(s): Bristol Myers Squibb
Methods: EMERGENT-2 and EMERGENT-3 were 5-week, randomized, double-blind, placebo-controlled trials in adults with schizophrenia experiencing acute psychosis, PANSS total score ≥80, and CGI-S score ≥4. Subjects were randomized 1:1 to receive X/T or placebo for 5 weeks. Efficacy analyses of the pooled modified intention-to-treat population included change from baseline to week 5 in PANSS total, PANSS Marder 5-factor, and individual PANSS items scores.
Results: Baseline characteristics were similar in X/T (n=231) and placebo (n=239) groups. X/T was associated with larger reductions in PANSS total score from baseline to week 5 compared with placebo (least squares mean difference [LSD]= - 9.2, P 0.0001, Cohen's d=0.59). Improvements with X/T compared with placebo persisted across PANSS Marder positive (LSD= -2.8), negative (LSD= -1.6), uncontrolled hostility (LSD= -1.4), disorganized thought (LSD= -1.9), and depression/anxiety (LSD= -1.5) factors (P 0.001 for all). The individual items that make up each Marder factor showed greater improvement with X/T compared with placebo, except for difficulty in abstract thinking, a component of the PANSS Marder negative subscale, in which score change from baseline was equivalent in both treatment groups.
Conclusion: In data pooled from the pivotal EMERGENT-2 and EMERGENT-3 trials, X/T demonstrated a consistent benefit across symptom domains among adults with schizophrenia as assessed by PANSS Marder 5-factor analysis.
Short Description: The poster presents data of pooled post hoc efficacy analyses of the phase 3 randomized, double-blind, placebo-controlled EMERGENT-2 and EMERGENT-3 trials of xanomeline and trospium chloride (X/T) vs placebo in adults with schizophrenia. The results showed a consistent benefit of X/T across symptoms of schizophrenia as assessed using PANSS Marder positive, negative, uncontrolled hostility, disorganized thought, and depression/anxiety factors.
Name of Sponsoring Organization(s): Bristol Myers Squibb
