Neuropsychiatric Disease and Treatment (Mar 2024)
Efficacy of HP-3070, A Once-Daily Asenapine Transdermal System, in the Treatment of Adults with Schizophrenia: A PANSS Five-Factor Analysis
Abstract
Leslie Citrome,1 Mariacristina Castelli,2 Masami Hasebe,3 Takaaki Terahara,3 Justin Faden,4 Marina Komaroff2 1Department of Psychiatry and Behavioral Sciences, New York Medical College, Valhalla, NY, USA; 2Product Development, Noven Pharmaceuticals, Inc, Jersey City, NJ, USA; 3Hisamitsu Pharmaceutical Co., Inc, Tokyo, Japan; 4Department of Psychiatry, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USACorrespondence: Leslie Citrome, Department of Psychiatry and Behavioral Sciences, New York Medical College, 40 Sunshine Cottage Road, Valhalla, NY, 10595, USA, Tel +1 845-362-2081, Email [email protected]: 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.Keywords: asenapine, transdermal, patch, schizophrenia, positive and negative syndrome scale, five-factor
