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

Published online by Cambridge University Press:  16 November 2016

Stephen R. Marder ,
Mika Juhani Hakala ,
Mette Krog Josiassen ,
Peter Zhang ,
John Ouyang ,
Emmanuelle Weiller ,
Catherine Weiss  and
Mary Hobart
Stephen R. Marder*
Affiliation:
Semel Institute for Neuroscience, University of California Los Angeles, Los Angeles, CA, USA
Mika Juhani Hakala
Affiliation:
H. Lundbeck A/S, Valby, Denmark
Mette Krog Josiassen
Affiliation:
H. Lundbeck A/S, Valby, Denmark
Peter Zhang
Affiliation:
Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA
John Ouyang
Affiliation:
Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA
Emmanuelle Weiller
Affiliation:
H. Lundbeck A/S, Valby, Denmark
Catherine Weiss
Affiliation:
Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA
Mary Hobart
Affiliation:
Otsuka Pharmaceutical Development & Commercialization Inc., Princeton, NJ, USA
*
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: [email protected]
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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.

Keywords

efficacymaintenancePANSSsafetyschizophrenia
Type
Original Articles
Information
Acta Neuropsychiatrica , Volume 29 , Issue 5 , October 2017 , pp. 278 - 290
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Copyright
© Scandinavian College of Neuropsychopharmacology 2016 

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