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Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale—supportive analyses from a Phase 3 study

Published online by Cambridge University Press:  19 June 2017

Leslie Citrome ,
Robert Risinger ,
Andrew J. Cutler ,
Yangchun Du ,
Jacqueline Zummo ,
Henry A. Nasrallah  and
Bernard L. Silverman
Leslie Citrome*
Affiliation:
New York Medical College, Valhalla, New York, USA
Robert Risinger
Affiliation:
NeuroRx Pharmaceuticals, Wilmington, Delaware, USA
Andrew J. Cutler
Affiliation:
Meridien Research, Bradenton, Florida, USA
Yangchun Du
Affiliation:
Alkermes, Inc., Waltham, Massachusetts, USA
Jacqueline Zummo
Affiliation:
Alkermes, Inc., Waltham, Massachusetts, USA
Henry A. Nasrallah
Affiliation:
Saint Louis University School of Medicine, St. Louis, Missouri, USA
Bernard L. Silverman
Affiliation:
Alkermes, Inc., Waltham, Massachusetts, USA
*
*Address for correspondence: Leslie Citrome, MD, MPH, 11 Medical Park Drive, Suite 106, Pomona, NY 10970, USA. (Email: citrome@cnsconsultant.com)
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Abstract

Objective

Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic that was evaluated for the treatment of schizophrenia in a randomized, placebo-controlled, Phase 3 study. Here, we present exploratory analyses of supportive efficacy endpoints.

Methods

Patients experiencing an acute exacerbation of schizophrenia received AL 441 mg intramuscularly (IM), AL 882 mg IM, or matching placebo IM monthly. Supportive endpoints included changes from baseline at subsequent time points in Clinical Global Impression-Severity (CGI-S) scale score; Positive and Negative Syndrome Scale (PANSS) Total score; PANSS Positive, Negative, and General Psychopathology subscale scores; PANSS Marder factors (post hoc); and PANSS responder rate. Overall response rate, based on PANSS Total score and Clinical Global Impression–Improvement (CGI-I) scale score, was also analyzed.

Results

Of 622 patients who were randomized, 596 had ≥1 post-baseline PANSS score. Patients were markedly ill at baseline (mean PANSS Total scores 92–94). Compared with placebo, CGI-S scores; PANSS Positive, Negative, and General Psychopathology subscale scores; and PANSS Marder factors were all significantly (p<0.001) improved by Day 85 with both AL doses, with significantly lower scores starting from Day 8 in most instances. Treatment response rates were significantly (p<0.001) greater with both doses of AL vs placebo.

Conclusion

AL demonstrated robust efficacy on CGI-S score, PANSS subscale scores, PANSS Marder factors, and response rates. Study limitations included use of a fixed dose for initial oral aripiprazole and fixed monthly AL doses without the option to individualize the oral initiation dosing or injection frequency for efficacy, tolerability, or safety.

Keywords

Antipsychotic treatmentaripiprazole lauroxilpsychotic symptomsresponseschizophrenia
Type
Original Research
Information
CNS Spectrums , Volume 23 , Issue 4 , August 2018 , pp. 284 - 290
Copyright
© Cambridge University Press 2017 

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