Thumbnail Image
Item

Efficacy of HP-3070, A Once-Daily Asenapine Transdermal System, in the Treatment of Adults with Schizophrenia: A PANSS Five-Factor Analysis

Citrome, Leslie
; 
Castelli, Mariacristina
; 
Hasebe, Masami
; 
Terahara, Takaaki
; 
Faden, Justin
; 
Komaroff, Marina
Citations
Altmetric:
Genre
Journal article
Date
2024-03-29
Advisor
Committee member
Group
Department
Psychiatry
Subject
Asenapine
 Five-factor
 Patch
 Positive and negative syndrome scale
 Schizophrenia
 Transdermal
Permanent link to this record
https://scholarshare.temple.edu/handle/20.500.12613/11868
Collections
Faculty/Researcher Works
Show all metadata
Files
Thumbnail Image
Faden-JournalArticle-2024-03.pdf
Adobe PDF, 581.18 KB
Research Projects
Organizational Units
Journal Issue
DOI
https://doi.org/10.2147/ndt.s439712
Abstract
Introduction: HP-3070, a once-daily asenapine transdermal system, is the first antipsychotic “patch” formulation FDA approved for adults with schizophrenia. Positive and Negative Syndrome Scale (PANSS) score items can be grouped into a five-factor structure to describe specific schizophrenia symptom domains. This post hoc analysis of data from a pivotal study evaluated HP-3070’s efficacy by examining these factors. Methods: In a phase 3 study, adults with an acute exacerbation of schizophrenia were randomized to six weeks of treatment with HP-3070 3.8mg/24h, 7.6mg/24h, or placebo. An analysis was performed using the five PANSS factor domains (negative symptoms, positive symptoms, disorganized thought, uncontrolled hostility/excitement, anxiety/depression). Mixed-model repeated-measures (MMRM) analysis included change from baseline (CFB) 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. Treatment with HP-3070 3.8mg/24h resulted in a statistically significant LS mean CFB (improvement) vs placebo at Weeks 4– 6 for all domains except for anxiety/depression, where a numerical difference was observed in favor of active treatments. Among the domains, the positive symptom factor demonstrated the numerically greatest LS mean (SE) difference from placebo in CFB, which for HP-3070 7.6mg/24h was − 2.0 [0.57] and for HP-3070 3.8mg/24h was − 2.3 [0.57]; P< 0.001 for both. Treatment effect size for the positive symptom factor using Cohen’s d (95% confidence intervals) was 0.39 (0.17, 0.61) for HP-3070 7.6mg/24h and 0.45 (0.20, 0.64) for HP-3070 3.8mg/24h. Discussion: Post hoc analysis using a PANSS five-factor model suggests that HP-3070 may address a broad range of symptoms in people with schizophrenia.
Description
Citation
Citrome L, Castelli M, Hasebe M, Terahara T, Faden J, Komaroff M. Efficacy of HP-3070, A Once-Daily Asenapine Transdermal System, in the Treatment of Adults with Schizophrenia: A PANSS Five-Factor Analysis. Neuropsychiatr Dis Treat. 2024;20:755-764 https://doi.org/10.2147/NDT.S439712
Citation to related work
Informa UK Limited
Has part
Neuropsychiatric Disease and Treatment, Vol. 20
ADA compliance
Embedded videos
License
Attribution-NonCommercial CC BY-NC
cbn