CNSPulse
T92

INPATIENT INITIATION OF THE LONG-ACTING INJECTABLE ANTIPSYCHOTIC ARIPIPRAZOLE LAUROXIL FOR THE TREATMENT OF ACUTE EXACERBATIONS 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

Treatment of schizophrenia exacerbations requires balancing acute symptom control with the longer-term goal of optimizing continued outpatient treatment. Long-acting injectable (LAI) formulations can address both goals when clinicians have an understanding of, and confidence in, LAI safety and efficacy. This report focuses on clinical outcomes for aripiprazole lauroxil (AL) initiated during hospitalization for acute schizophrenia.

Methods

This post-hoc analysis assessed the 2-week inpatient period of the 25-week ALPINE study, which evaluated AL (active control: paliperidone palmitate) for treatment of acutely exacerbated schizophrenia. Patients enrolled as inpatients and randomized to AL 1064mg every-2-months, started after a 1-day initiation regimen (AL NanoCrystal Dispersion plus one 30mg oral aripiprazole dose), were included. Efficacy was assessed using the Positive and Negative Syndrome Scale (PANSS). Early treatment response was defined as ≥20% reduction in PANSS total score from baseline (predose) to discharge. Safety was assessed based on adverse events (AEs).

Results

Ninety-nine patients were randomized to AL; 90 (90.9%) patients completed the 2week treatment period. Mean (SD) baseline PANSS total score was 94.1 (9.0). At day 15, least-squares mean (SE) change from baseline in PANSS total score was –15.4 (1.3) for ALtreated patients; 55.2% met early treatment response criteria. Common AEs (≥5%) were injection site pain (15.2%), akathisia (9.1%), and headache (5.1%).

Conclusion

Initiation of AL can be completed with a 1-day regimen in hospitalized patients, providing symptom reduction with confidence of having drug on board to support the transition to outpatient care. Funding Statement: This study was funded by Alkermes, Inc. Medical writing and editorial support were provided by Peloton Advantage, LLC, an OPEN Health company, and funded by Alkermes, Inc.