CNSPulse
T93

SAFETY AND EFFICACY OF ARIPIPRAZOLE LAUROXIL IN AN OUTPATIENT SETTING AFTER INITIATION DURING HOSPITALIZATION FOR AN ACUTE EXACERBATION OF SCHIZOPHRENIA

Peter J. Weiden — MD1, Jelena Kunovac, MD, MS2, Shifang Liu, PhD3, Daniel J. Kim, PhD3, James A. McGrory, PhD3 1Renaissance School of Medicine at Stony Brook University, 2Redbird Research, Excell Research; University of Nevada, 3Alkermes, Inc.

2026 ASCP Annual Meeting

Background

The period following discharge from an acute schizophrenia hospitalization carries a high risk of relapse, rehospitalization, suicide, and medication nonadherence. Treatment strategies must prioritize sustained symptom control beyond discharge. Aripiprazole lauroxil (AL) is a long-acting injectable antipsychotic that can be initiated during acute care, ensuring adequate coverage after discharge to bridge inpatient stabilization with outpatient maintenance.

Methods

This post-hoc analysis focused on the outpatient period of a 25-week phase 3b study evaluating the use of AL (with paliperidone palmitate as active control) started during a short hospitalization for acute schizophrenia. Adult patients who were enrolled as inpatients, randomized to AL (1064mg every-2-months), discharged after 2–3 weeks, and followed as outpatients (≤23 weeks) were included. Efficacy was evaluated using Positive and Negative Syndrome Scale (PANSS) scores, and safety was monitored based on adverse events (AEs), both from day of hospital discharge through the end of study.

Results

Of 99 patients randomized to AL, 84 (84.8%) remained in the study postdischarge; 56 (66.7%) completed outpatient treatment. After acute inpatient symptom improvement, mean (SD) PANSS total score was 77.3 (14.2) at discharge; additional least-squares mean (SE) change was –5.3 (1.3) at 23 weeks postdischarge. The most common AE (≥5%) was weight increase (10.7%). Six patients (7.1%) discontinued because of AEs.

Conclusion

After inpatient initiation of AL every-2-months, schizophrenia symptom severity remained stable during outpatient care. AL’s safety and tolerability profile supports its use for maintenance treatment following transition from inpatient care. Funding Statement: Sponsored by Alkermes, Inc. Writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Alkermes, Inc.