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167 Randomized, Double-Blind, Active-Controlled Study of Starting Aripiprazole Lauroxil with 1-Day Initiation in Acutely Ill Patients with Schizophrenia

Published online by Cambridge University Press:  24 April 2020

Peter J. Weiden ,
Amy Claxton ,
Yangchun Du ,
Sergey Yagoda ,
David Walling  and
Jelena Kunovac
Peter J. Weiden
Affiliation:
Senior Medical Director, Medical Affairs, Alkermes, Inc., Waltham, MA
Amy Claxton
Affiliation:
Director, Clinical Research, Alkermes, Inc., Waltham, MA
Yangchun Du
Affiliation:
Senior Director, Biostatistics, Alkermes, Inc., Waltham, MA
Sergey Yagoda
Affiliation:
Associate Medical Director, Clinical Research, Alkermes, Inc., Waltham, MA
David Walling
Affiliation:
CEO and Principal Investigator, CNS Network, LLC, Garden Grove, CA
Jelena Kunovac
Affiliation:
CEO and CMO, Altea Research, Las Vegas, NV
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Abstract:

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Objective:

Evaluate efficacy and safety of a 2-month dose of aripiprazole lauroxil (AL) with a 1-day initiation regimen during hospitalization for an acute exacerbation of schizophrenia.

Methods:

In the phase 3b double-blind ALPINE study, adults with schizophrenia were randomized to AL (AL NanoCrystal® Dispersion + oral aripiprazole 30 mg day 1; AL 1064 mg day 8 and every 8 weeks) or paliperidone palmitate (PP 234 mg day 1; PP 156 mg day 8 and every 4 weeks). Patients were discharged after 2 weeks of hospitalization and followed through week 25. Primary endpoint was within-group changes in PANSS total score from baseline to week 4 (observed cases). Secondary analyses included within-group changes at weeks 9 and 25 (observed) and between-group comparisons at weeks 4, 9, and 25 (MMRM). Adverse events (AEs) were monitored throughout the study.

Results:

200 patients were randomized (AL, n=99; PP, n=101); 56.6% and 42.6%, respectively, completed the study. Within-group changes from baseline in PANSS were −17.4 for AL and −20.1 for PP at week 4 (both groups, P<0.001) and continued to decline at weeks 9 (AL, −19.8; PP, −22.5) and 25 (AL, −23.3; PP, −21.7). The change in PANSS over time was similar between groups. AEs occurring in ≥10% of patients in either group were injection site pain (AL, 17.2%; PP, 24.8%), akathisia (AL, 9.1%; PP, 10.9%), and weight increased (AL, 9.1%; PP, 16.8%).

Conclusions:

AL and PP were effective and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing in the outpatient setting.

Funding Acknowledgements:

This study was funded by Alkermes, Inc.

Type
Abstracts
Information
CNS Spectrums , Volume 25 , Issue 2 , April 2020 , pp. 306 - 307
Copyright
© Cambridge University Press 2020