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

Abstract: Background: HP-3070, a once-daily asenapine transdermal system, is FDA-approved for adults with schizophrenia. The Positive and Negative Syndrome Scale (PANSS) score’s five-factor structure can assess treatment efficacy across different domains. This post-hoc analysis of a pivotal study evaluated the efficacy of HP-3070 by examining these domains. Methods: In a phase 3 study, adults with acute exacerbations of schizophrenia were randomized to six 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. Conclusion: 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, which suggests that HP-3070 may address a broad range of symptoms in schizophrenia.Short Description: This post-hoc analysis of a phase 3 randomized study investigated the efficacy of HP-3070, a transdermal system that delivers asenapine via a once-daily “patch,” using a PANSS five-factor model. HP-3070 demonstrated treatment effects on negative symptoms, positive symptoms, disorganized thought, uncontrolled hostility/excitement, and anxiety/depression. These findings suggest that HP-3070 may impact a broad range of symptoms that are present in patients with schizophrenia.Name of Sponsoring Organization(s): Noven Pharmaceuticals, Inc.