Safety and Effectiveness of Lurasidone in Patients with Schizophrenia: A 12-Week, Open-Label Extension Study

Masaomi Iyo,1 Jun Ishigooka,2 Masatoshi Nakamura,3 Reiko Sakaguchi,4 Keisuke Okamoto,5 Yongcai Mao,6 Joyce Tsai,7 Alison Fitzgerald,8 Kentaro Takai,9 Teruhiko Higuchi10,11 1Department of Psychiatry, Graduate School of Medicine, Chiba University, Chiba, Japan; 2Institute of CNS Pharmacology, Tokyo, Japan; 3Department of Data Science, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan; 4Department of Clinical Research, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan; 5Department of Clinical Operation, Drug Development Division, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan; 6Division of Data Science, Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA; 7Division of Clinical Research, Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA; 8Division of Clinical Operations, Sunovion Pharmaceuticals Inc., Fort Lee, NJ, USA; 9Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan; 10Japan Depression Center, Tokyo, Japan; 11National Center of Neurology and Psychiatry, Tokyo, JapanCorrespondence: Kentaro Takai Email kentaro-takai@ds-pharma.co.jpPurpose: The goal of this study was to evaluate the safety and effectiveness of lurasidone among patients with schizophrenia in a 12-week open-label extension study.Patients and Methods: Patients who completed a 6-week, double-blind, placebo-controlled study were enrolled in a 12-week open-label extension study with flexible dosing of lurasidone at 40 or 80 mg/day. Safety assessments included adverse events, vital signs, laboratory tests, and electrocardiogram (ECG) parameters. Effectiveness measures included the Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression-Severity Scale (CGI-S), Calgary Depression Scale for Schizophrenia (CDSS) and quality of life measure.Results: A total of 289 patients were enrolled in the open-label extension study. Rates of treatment-emergent adverse events (TEAEs) were low; akathisia was the most common TEAE with an incidence of 6.6%. There were 54 patients (18.7%) who discontinued the extension study, with 17 (5.9%) discontinuing due to adverse events. Minimal or no effects of lurasidone on weight, body mass index, metabolic parameters, prolactin, and ECG parameters were evident. There was continued improvement to week 12 in PANSS and CGI-S scores beyond the initial gains made during the prior 6-week double-blind study. Non-responders to lurasidone 40 mg/day in the prior 6-week study showed a mean (standard deviation) improvement from open-label baseline of 10.7 (13.8) points on the PANSS total score after lurasidone dose was increased to a modal dose of 80 mg/day during the extension study. Changes from double-blind baseline in CDSS and quality of life were maintained in the extension study.Conclusion: Treatment with lurasidone 40 or 80 mg once daily (flexibly dosed) continued to be well tolerated with patients demonstrating further improvement in symptoms over the course of a 12-week open-label extension study in patients with schizophrenia.Keywords: lurasidone, schizophrenia, antipsychotic, safety, effectiveness, open-labe