PM384. The effect of brexpiprazole (OPC-34712) versus aripiprazole in adult patients with acute schizophrenia: an exploratory study

Abstract

Leslie Citrome MD, MPH 1 , Ai Ota BSc 2 , Kazuhiro Nagamizu BSc 2 , Pamela Perry MSc 3 , Emmanuelle Weiller PsyD 4 , Ross Baker PhD MBA 3 1 New York Medical College, Valhalla, NY, USA 2 Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan 3 Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA 4 H. Lundbeck A/S, Valby, Denmark Abstract Background: Brexpiprazole is a serotonin-dopamine activity modulator that acts as a partial agonist at 5-HT1A and dopamine D2 receptors, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors, all at similar potencies. Brexpiprazole has lower intrinsic activity at the D2 receptor than aripiprazole, suggesting a lower potential to induce D2 agonist-mediated adverse events such as akathisia, insomnia, restlessness, and nausea. In this open-label study the effects of 6-week treatment with brexpiprazole or aripiprazole in patients with schizophrenia were explored (NCT02054702). Methods: Patients with an acute relapse of schizophrenia were randomized to receive brexpiprazole 1 to 4mg/day (3mg/day target dose) or aripiprazole 10 to 20 mg/day (15 mg/day target dose) for 6 weeks. The mean change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to Week 6 was analysed. Results: A total of 97 patients were treated with brexpiprazole (N=64) or aripiprazole (N=33). A reduction in the symptoms of schizophrenia assessed by the PANSS total score were observed in both treatment groups (LS mean change at week 6: -22.9 and -19.4 for brexpiprazole and aripiprazole, respectively). Brexpiprazole was well tolerated and the incidence of EPS-related adverse events including akathisia was lower in the patients treated with brexpiprazole (14.1%) compared with the patients treated with aripiprazole (30.3%). Conclusion: Clinically relevant improvements in psychopathology were observed in patients with acute schizophrenia treated with brexpiprazole or aripiprazole. Brexpiprazole was well tolerated with a lower incidence of EPS-related adverse events than aripiprazole.