Long-term safety and Effectiveness of Lurasidone in Adolescents and Young Adults With Schizophrenia: Pooled Post-hoc Analyses of Two 12-month Extension Studies

Abstract: Introduction: The aim of this pooled analysis was to evaluate the long-term safety and effectiveness of lurasidone in the treatment of schizophrenia in adolescents (13-17 years) and young adults (18-25 years). Methods: The 2 pooled studies used similar designs and outcome measures. Patients (13-25 years) with schizophrenia completed an initial double-blind 6-week trial of lurasidone (40 and 80 mg/d), and (80 and 160 mg/d) in the young adult trial. In the open label long-term trials, adolescent patients were treated with 20-80 mg/d of lurasidone, and adults were treated with 40-160 mg/d of lurasidone. Efficacy was evaluated based on the Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-Severity Scale (CGI-S). Results: The safety population consisted of 306 patients (mean age, 16.2 years; 208 patients (68.0%) who completed 12 months of treatment; 8.2% discontinued by 12 months due to an adverse event. Mean (SD) change in the PANSS total score from extension Baseline to Months 6 and 12 was -11.8 (13.9) and -15.3 (15.0), respectively (OC); and mean (SD) change in the CGI-S score was -0.8 (1.0) and -1.0 (1.1), respectively (OC). The most frequent adverse events were headache (17.6%), anxiety (11.4%), schizophrenia (9.8%), and nausea (9.8). No clinically meaningful changes were observed in weight, metabolic parameters, or prolactin. Conclusions: In adolescents and young adults with schizophrenia, treatment with lurasidone was generally well-tolerated and effective. Long-term treatment was associated with continued reduction in symptoms of schizophrenia. Long-term treatment was associated with minimal effects on weight, metabolic parameters, and prolactin.Short Description: Earlier onset of schizophrenia, which occurs more commonly in males, is characterized by greater illness severity, chronicity and functional impairment with a less favorable prognosis than later onset schizophrenia. This poster summarizes the results of a post-hoc analysis in adolescents and young adults with schizophrenia demonstrating that long-term treatment with lurasidone was associated with continued reduction in symptoms of schizophrenia, with minimal effects on weight, metabolic parameters, and prolactin.Name of Sponsoring Organization(s): Supported by Funding from Angelini Pharma S.p.A. and Sunovion Pharmaceuticals Inc.