Brexpiprazole is a serotonin-dopamine activity modulator that is a partial agonist at 5-HT1A and dopamine D2 receptors at similar potency, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.

To evaluate the efficacy, safety, and tolerability of brexpiprazole in patients with acute schizophrenia in a meta-analysis of three phase 3 studies with brexpiprazole.

The primary endpoint was change from baseline to week 6 in PANSS total score.

Data from the 3 clinical studies in patients with acute schizophrenia were combined and analyzed using individual patient data meta-analysis. In two similarly designed studies (NCT01396421; NCT01393613), patients with acute schizophrenia were randomized to fixed-doses of brexpiprazole 2 mg/day, 4 mg/day or placebo (a low-dose treatment group was included in each study [0.25 mg and 1.0 mg]; not included in the meta-analysis). In the third study (NCT01810380), patients were randomized to flexible dosing of brexpiprazole (2 to 4 mg/day), placebo, or an active reference (quetiapine extended release). Changes from baseline for brexpiprazole vs. placebo were analyzed using an MMRM approach.

Brexpiprazole 2–4 mg (n = 868) was superior to placebo (n = 517) in change from baseline in PANSS total score (−20.1 vs. −14.3; estimated treatment difference to placebo: −5.8 [95% CI: −8.0; −3.6]; P < 0.001). The proportions of patients reporting TEAEs were similar between the brexpiprazole and placebo treatment groups (57.9% vs. 57.5%). No unexpected safety concerns were observed.

This meta-analysis supports evidence from three individual trials that brexpiprazole is efficacious and safe in treating patients with acute schizophrenia.

The authors have not supplied their declaration of competing interest.