Poster
93
(#93) Antihostility Effects of Xanomeline and Trospium Chloride in Subjects With Schizophrenia: Post Hoc Pooled Analyses of EMERGENT-1, EMERGENT-2, and EMERGENT-3 Trials
Psych Congress 2025
Abstract: Background: In addition to hallucinations and delusions, people with schizophrenia may exhibit hostility, which is associated with aggressive and violent behavior during acute exacerbations. Prior research has demonstrated the specific antihostility effects of several atypical antipsychotics. The objective of this post hoc analysis of 3 acute trials was to assess the efficacy of xanomeline and trospium chloride (X/T) in reducing hostility in subjects with schizophrenia.
Methods: Pooled data from the 5-week, randomized, double-blind, placebo-controlled, inpatient EMERGENT-1 (NCT03697252), EMERGENT-2 (NCT04659161), and EMERGENT-3 (NCT04738123) trials were assessed. Subjects aged 18-65 years experiencing acute exacerbation of psychotic symptoms received placebo or X/T titrated over 7 days to 125mg/30mg twice daily. Mean change in the Positive and Negative Syndrome Scale (PANSS) hostility item (P7) score was assessed, and pseudospecificity was addressed by adjusting for positive symptom change and somnolence.
Results: Subject demographics and disease characteristics were similar across groups. In individuals with baseline PANSS hostility scores ≥2, ≥3, or ≥4, improvement in hostility from baseline to week 5 was greater among those receiving X/T than in those receiving placebo. This improvement was maintained when adjusted for PANSS positive symptom change and somnolence.
Conclusion: This post hoc analysis of data pooled from the short-term EMERGENT trials demonstrates that X/T has a specific antihostility effect compared with placebo in subjects experiencing an acute exacerbation of schizophrenia.
Short Description: Xanomeline and trospium chloride showed specific antihostility effects (using item P7 of Positive and Negative Syndrome Scale, controlling for other psychotic symptoms and sedation) in subjects with acute schizophrenia in post hoc analyses of data pooled from the short-term EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials.
Name of Sponsoring Organization(s): Bristol Myers Squibb
Methods: Pooled data from the 5-week, randomized, double-blind, placebo-controlled, inpatient EMERGENT-1 (NCT03697252), EMERGENT-2 (NCT04659161), and EMERGENT-3 (NCT04738123) trials were assessed. Subjects aged 18-65 years experiencing acute exacerbation of psychotic symptoms received placebo or X/T titrated over 7 days to 125mg/30mg twice daily. Mean change in the Positive and Negative Syndrome Scale (PANSS) hostility item (P7) score was assessed, and pseudospecificity was addressed by adjusting for positive symptom change and somnolence.
Results: Subject demographics and disease characteristics were similar across groups. In individuals with baseline PANSS hostility scores ≥2, ≥3, or ≥4, improvement in hostility from baseline to week 5 was greater among those receiving X/T than in those receiving placebo. This improvement was maintained when adjusted for PANSS positive symptom change and somnolence.
Conclusion: This post hoc analysis of data pooled from the short-term EMERGENT trials demonstrates that X/T has a specific antihostility effect compared with placebo in subjects experiencing an acute exacerbation of schizophrenia.
Short Description: Xanomeline and trospium chloride showed specific antihostility effects (using item P7 of Positive and Negative Syndrome Scale, controlling for other psychotic symptoms and sedation) in subjects with acute schizophrenia in post hoc analyses of data pooled from the short-term EMERGENT-1, EMERGENT-2, and EMERGENT-3 trials.
Name of Sponsoring Organization(s): Bristol Myers Squibb
