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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 nntman@gmail.comIntroduction: 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

Priyanka Kolli,1 Grace Kelley,1 Marianela Rosales,2 Justin Faden,1 Ryan Serdenes3 1Department of Psychiatry, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA; 2Department of Psychiatry and Human Behavior, Thomas Jefferson University Hospital, Philadelphia, PA, USA; 3Department of Psychiatry, Johns Hopkins School of Medicine, Baltimore, MD, USACorrespondence: Ryan Serdenes, Email rserdenes@gmail.comAbstract: Olanzapine is one of the most widely used antipsychotics since its initial approval by the US Food and Drug Administration in 1996 and has undergone extensive pharmacokinetic study. Despite being utilized in clinical psychiatry for decades, there remain questions regarding the variety of available formulations, the utility of therapeutic drug monitoring, altered kinetic properties in special populations/medical illnesses, the use of high-dose olanzapine, and drug interactions, among many others. We performed a narrative literature review of olanzapine pharmacokinetics in June 2023 using the US National Library of Medicine’s PubMed.gov resource (https://www.ncbi.nlm.nih.gov/pubmed) and Google Scholar. Herein, we review clinically relevant aspects of olanzapine pharmacokinetic data while highlighting knowledge gaps and potential areas of future study.Keywords: olanzapine, pharmacokinetics, drug-drug interactions, pharmacodynamics, clinical psychopharmacology