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

• Published in: Neuropsychiatric disease and treatment 2024-01, Vol.20, p.755-764
• Main Authors: Citrome, Leslie, Castelli, Mariacristina, Hasebe, Masami, Terahara, Takaaki, Faden, Justin, Komaroff, Marina
• Format: Article
• Language: English
• Subjects: Adults; Antipsychotics; Anxiety; Asenapine; Clinical Trial Report; Dosage and administration; Drug dosages; Drug therapy; Drug withdrawal; Emotional behavior; Evidence-based medicine; Factor analysis; five-factor; Hostility; Insomnia; Mental depression; Mental disorders; patch; Patient compliance; Patients; Pharmaceutical industry; Pharmaceutical research; Physiological aspects; Placebos; positive and negative syndrome scale; Psychotropic drugs; Schizophrenia; Statistical analysis; Taste disorders; Testing; transdermal; Transdermal medication
• ISSN: 1176-6328; 1178-2021; 1178-2021
• DOI: 10.2147/NDT.S439712

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. 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. 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];