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Factor Analysis Investigating the Efficacy of HP-3070 Transdermal System in Positive and Negative Syndrome Scale Five Adults With Schizophrenia

Published online by Cambridge University Press:  14 April 2023

Leslie Citrome ,
Mariacristina Castelli ,
Sandeep Byreddy ,
Masami Hasebe ,
Takaaki Terahara ,
Justin Faden  and
Marina Komaroff
Leslie Citrome
Affiliation:
Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA
Mariacristina Castelli
Affiliation:
Product Development, Noven Pharmaceuticals, Inc., Jersey City, NJ, USA
Sandeep Byreddy
Affiliation:
Product Development, Noven Pharmaceuticals, Inc., Jersey City, NJ, USA
Masami Hasebe
Affiliation:
Hisamitsu Pharmaceutical Co., Inc., Chiyoda-ku, Tokyo, Japan
Takaaki Terahara
Affiliation:
Hisamitsu Pharmaceutical Co., Inc., Chiyoda-ku, Tokyo, Japan
Justin Faden
Affiliation:
Department of Psychiatry, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA
Marina Komaroff
Affiliation:
Product Development, Noven Pharmaceuticals, Inc., Jersey City, NJ, USA
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Abstract

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Introduction

HP-3070, a once-daily asenapine transdermal system, is FDA-approved for adults with schizophrenia. In a pivotal phase 3 randomized controlled study, patients with schizophrenia who were treated once daily with HP-3070 demonstrated significant improvement in Positive and Negative Syndrome Scale (PANSS) total scores compared with placebo. The PANSS score’s five-factor structure can also assess treatment efficacy across different domains. This post-hoc analysis of the pivotal study evaluated the efficacy of HP-3070 by examining these domains.

Methods

In the pivotal phase 3 study, adults with acute exacerbations of schizophrenia were randomized to 6 weeks of treatment with HP-3070 3.8mg/24h, 7.6mg/24h, or placebo. Factor analysis of PANSS scores was performed using five domains (negative symptoms, positive symptoms, disorganized thought, uncontrolled hostility/excitement, anxiety/depression). Mixed-model repeated-measures (MMRM) analysis included change from baseline in PANSS factor score as the repeated dependent variable, with country, treatment, visit, treatment by visit interaction, and baseline PANSS score as covariates.

Results

The analysis included 607 patients. Least-squares mean estimates (standard error) of the difference from placebo in change from baseline to Week 6 for each factor were as follows: negative symptoms, 3.8mg/24h, -0.9 (0.43), P=0.045, and 7.6mg/24h, -0.4 (0.43), P=0.41; positive symptoms, 3.8mg/24h, -2.3 (0.57), P<0.001, and 7.6mg/24h, -2.0 (0.57), P<0.001; disorganized thought, 3.8mg/24h, -1.5 (0.38), P<0.001, and 7.6mg/24h, -0.9 (0.38), P=0.03; uncontrolled hostility/excitement: 3.8mg/24h, -1.1 (0.30), P<0.001, and 7.6mg/24h -0.9 (0.30), P=0.002; anxiety/depression, 3.8mg/24h, -0.5 (0.31), P=0.14, and 7.6mg/24h, -0.6 (0.31), P=0.07.

Conclusions

HP-3070 demonstrated treatment effects on a PANSS five-factor model, with the results indicating impact on negative symptoms, positive symptoms, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression. These findings suggest that HP-3070 may address a broad range of symptoms in schizophrenia.

Funding

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical, Co.

Type
Abstracts
Information
CNS Spectrums , Volume 28 , Issue 2 , April 2023 , pp. 243 - 244
Copyright
© The Author(s), 2023. Published by Cambridge University Press