Brexpiprazole for the maintenance treatment of adults with schizophrenia: an evidence-based review and place in therapy

Abstract: The purpose of this review is to describe the available data for brexpiprazole in the maintenance treatment of schizophrenia. This objective was completed by searching the databases PubMed, Embase, and ClinicalTrials.gov to identify relevant study results presented as papers or abstracts. In summary, brexpiprazole is a new agent in the D 2 partial agonist class that has a unique receptor-binding profile, based in part on high affinity for serotonin 5HT 1A and 5HT 2A receptors, paired with lower intrinsic activity at dopamine D 2 receptors. The average dose used in efficacy and safety studies for the maintenance treatment of schizophrenia ranged from 3.0 and 3.1 mg in the open-label safety studies to 3.6 mg in the double-blind randomized relapse-prevention study. Highlights from the 52-week double-blind placebo-controlled relapse-prevention trial evidenced rates of relapse in the brexpiprazole group of 13.5% vs 38.5% in the placebo group (number needed to treat 4, 95% CI 3–8; P <0.0001). Safety data indicate that brexpiprazole is tolerated well, with rates of discontinuation due to treatment-emergent adverse events that ranged from 5.2% of those taking brexpiprazole in the double-blind maintenance phase of the relapse-prevention trial to 15.3% in a 52-week open-label safety study. In the available trials, there were relatively low rates of akathisia, and the degree of weight gain was similar to that seen in studies with aripiprazole for the treatment of schizophrenia. Positive and Negative Syndrome Scale scores also remained relatively stable in the open-label safety studies. Available data indicate that brexpiprazole is an effective agent for the maintenance treatment of schizophrenia that is overall well tolerated. Keywords: akathisia, weight gain, second-generation antipsychotics, atypical antipsychotics, relapse prevention