Poster
100
(#100) Symptom Stability During Treatment Transition to Xanomeline and Trospium Chloride: Post Hoc Analysis of an Inpatient Trial in Schizophrenia
Psych Congress 2025
Background: Individuals with schizophrenia often switch antipsychotics. A trial of xanomeline and trospium chloride (X/T) requiring washout of prior antipsychotics (pAPD) provided an opportunity to examine safety and disease symptom stability during this transition.
Methods: An open-label, 2-cohort inpatient trial (NCT06572449) enrolled symptomatically stable adults with schizophrenia with PANSS total scores ≤80. Following a washout period, participants began treatment with X/T BID on an empty stomach for 4 weeks starting at 50mg/20mg and were then uptitrated to a maximum 125mg/30mg (Cohort 1) or 100mg/20mg (Cohort 2). Treatment continued for an additional 4 weeks at the maximum tolerated dose with food. PANSS total scores from the 2 cohorts were pooled and analyzed by pAPD and washout duration (WOD) during the transition from pAPD to X/T.
Results: A total of 168 participants had calculable washout periods at baseline. Median (min, max) WOD was 3 (1, 6) days. Mean±SD PANSS total scores were stable from screening (63.4±10.9) to baseline (64.1±10.7) and independent of WOD (r=0.05). Mean±SD changes from screening to baseline in PANSS total score for individuals previously on aripiprazole, olanzapine, quetiapine, or risperidone were 1.5±4.8 (n=11), -0.4±3.2 (n=36), 0.9±6.2 (n=48), and 0.8±3.5 (n=35), respectively. PANSS total score improved from baseline to day 56 with X/T regardless of pAPD and WOD.
Conclusion: Overall, increases in PANSS total scores from screening to baseline were not seen when switching individuals from pAPD to X/T. These data suggest that stable individuals can be safely transitioned from pAPD to X/T without destabilization of schizophrenia symptoms.
Short Description: Short description: Individuals with schizophrenia often switch antipsychotics. Safety and symptom stability stratified by prior antipsychotic (pAPD) and washout duration were assessed in an open-label, 2-cohort, inpatient trial evaluating the impact of dosing X/T with food on safety
and efficacy of X/T in individuals with schizophrenia. Results suggest that treatment transition to X/T requiring washout of pAPD did not affect symptom stability.
Name of Sponsoring Organization(s): Bristol Myers Squibb
Methods: An open-label, 2-cohort inpatient trial (NCT06572449) enrolled symptomatically stable adults with schizophrenia with PANSS total scores ≤80. Following a washout period, participants began treatment with X/T BID on an empty stomach for 4 weeks starting at 50mg/20mg and were then uptitrated to a maximum 125mg/30mg (Cohort 1) or 100mg/20mg (Cohort 2). Treatment continued for an additional 4 weeks at the maximum tolerated dose with food. PANSS total scores from the 2 cohorts were pooled and analyzed by pAPD and washout duration (WOD) during the transition from pAPD to X/T.
Results: A total of 168 participants had calculable washout periods at baseline. Median (min, max) WOD was 3 (1, 6) days. Mean±SD PANSS total scores were stable from screening (63.4±10.9) to baseline (64.1±10.7) and independent of WOD (r=0.05). Mean±SD changes from screening to baseline in PANSS total score for individuals previously on aripiprazole, olanzapine, quetiapine, or risperidone were 1.5±4.8 (n=11), -0.4±3.2 (n=36), 0.9±6.2 (n=48), and 0.8±3.5 (n=35), respectively. PANSS total score improved from baseline to day 56 with X/T regardless of pAPD and WOD.
Conclusion: Overall, increases in PANSS total scores from screening to baseline were not seen when switching individuals from pAPD to X/T. These data suggest that stable individuals can be safely transitioned from pAPD to X/T without destabilization of schizophrenia symptoms.
Short Description: Short description: Individuals with schizophrenia often switch antipsychotics. Safety and symptom stability stratified by prior antipsychotic (pAPD) and washout duration were assessed in an open-label, 2-cohort, inpatient trial evaluating the impact of dosing X/T with food on safety
and efficacy of X/T in individuals with schizophrenia. Results suggest that treatment transition to X/T requiring washout of pAPD did not affect symptom stability.
Name of Sponsoring Organization(s): Bristol Myers Squibb
