Response to inhaled loxapine in patients with schizophrenia or bipolar I disorder: PANSS-EC responder analyses

Abstract

Background Efficacy of inhaled loxapine 5 or 10 mg in treating agitation was shown using the Positive and Negative Syndrome Scale – Excited Component (PANSS-EC) in two Phase III randomised, double-blind, placebo-controlled trials in 344 agitated patients with schizophrenia and 314 patients with bipolar I disorder (Clinicaltrials.gov: NCT00628589, NCT00721955). Aims To examine the five individual items comprising the PANSS-EC and the percentage of patients achieving a clinical response (reduction of ≥40%) in PANSS-EC (Response-40) for these two studies. Method Response-40 was examined at the primary end-point (2 h) and over time. Results Response-40 and each PANSS-EC item score were statistically significant v. placebo at 2 h and at each assessment time point for both doses. Conclusions Inhaled loxapine produced rapid improvement in agitated patients with schizophrenia or bipolar I disorder, achieving Response-40 at the first assessment (10 min post dose). These results highlight the effectiveness of loxapine across all components of agitation as measured by the PANSS-EC.