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Brexpiprazole in patients with schizophrenia: overview of short- and long-term phase 3 controlled studies

  • Stephen R. Marder (a1), Mika Juhani Hakala (a2), Mette Krog Josiassen (a2), Peter Zhang (a3), John Ouyang (a3), Emmanuelle Weiller (a2), Catherine Weiss (a3) and Mary Hobart (a3)...

Abstract

Objective

Review efficacy, safety, and tolerability of brexpiprazole in patients with schizophrenia in short- and long-term phase 3 studies.

Methods

Patients experiencing a current exacerbation of schizophrenia received brexpiprazole in two fixed-dose (2 and 4 mg), 6-week, placebo-controlled studies, one flexible-dose (2–4 mg), 6-week, placebo-control and active reference study, and one fixed-dose (1–4 mg), 52-week, placebo-controlled maintenance study.

Results

The efficacy of brexpiprazole was demonstrated in the two short-term fixed-dose studies with statistically significant improvements from baseline in Positive and Negative Syndrome Scale (PANSS) total score compared with placebo. In the flexible-dose short-term study, treatment with brexpiprazole resulted in numerically greater improvements in PANSS total score than with placebo that approached statistical significance (p=0.056). A meta-analysis of these short-term studies showed a mean change in PANSS total score of −20.1, reflecting a clinically meaningful reduction in symptoms. In the maintenance study, brexpiprazole had a beneficial effect relative to placebo on time to exacerbation of psychotic symptoms/impending relapse (p<0.0001). For all studies, brexpiprazole demonstrated clinically meaningful treatment effects on the Personal and Social Performance scale. Brexpiprazole had a favourable safety profile, with a relatively low prevalence of activating and sedating side effects. Weight gain in the short-term studies was ~1 kg greater than placebo. No safety concerns were observed with brexpiprazole in laboratory values, electrocardiogram, or vital signs.

Conclusions

Overall, the results indicate brexpiprazole, used either short-term or as part of a long-term maintenance treatment programme, is an efficacious therapy option in adults with schizophrenia and has a favourable safety/tolerability profile.

Copyright

Corresponding author

Dr. Stephen R Marder, Semel Institute for Neuroscience, University of California Los Angeles, 11301 Wilshire Blvd., MIRECC Building 210, Rm 130, Los Angeles, CA 90073, USA. Tel: 310 268 3647; Fax: 310 268 4056; E-mail: marder@ucla.edu

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