Key clinical point: Brexpiprazole is effective and well tolerated in schizophrenia patients with severe symptoms.

Major finding: At 6 weeks, brexpiprazole significantly reduced Positive and Negative Syndrome Scale (PANSS) total score (least-squares mean difference [LSMD], −6.76; P less than .0001) and Personal and Social Performance scale score (LSMD, 4.38; P = .0001) in more severely ill patients compared with the control group. At 52 weeks, brexpiprazole showed improvement in PANSS total score (mean [standard deviation], −32.1 [15.0]). Brexpiprazole vs. placebo showed a similar incidence of treatment-emergent adverse events over 6 weeks, regardless of severity.

Study details: This was a pooled analysis of 3 randomized, double-blind, placebo-controlled studies and 2 open-label extension studies.

Disclosures: This study was funded by Otsuka Pharmaceutical Development & Commercialization Inc. and H. Lundbeck A/S, Valby, Denmark. Three authors are full-time employees of Otsuka Pharmaceutical Development & Commercialization Inc. One author is a full-time employee of H. Lundbeck A/S. One of the authors has received research funding from Janssen and honoraria/consulting fees from Avanir, Janssen, Lundbeck, Otsuka, and Sunovion in the last 3 years.