title: Brexpiprazole in patients with schizophrenia: overview of short- and long-term phase 3 controlled studies.
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.
authors.affiliation: 1Semel Institute for Neuroscience,University of California Los Angeles,Los Angeles,CA,USA.
authors.forename: Stephen R
authors.initials: SR
authors.lastname: Marder
authors.affiliation: 2H. Lundbeck A/S,Valby,Denmark.
authors.forename: Mika Juhani
authors.initials: MJ
authors.lastname: Hakala
authors.affiliation: 2H. Lundbeck A/S,Valby,Denmark.
authors.forename: Mette Krog
authors.initials: MK
authors.lastname: Josiassen
authors.affiliation: 3Otsuka Pharmaceutical Development & Commercialization Inc.,Princeton,NJ,USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Zhang
authors.affiliation: 3Otsuka Pharmaceutical Development & Commercialization Inc.,Princeton,NJ,USA.
authors.forename: John
authors.initials: J
authors.lastname: Ouyang
authors.affiliation: 2H. Lundbeck A/S,Valby,Denmark.
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Weiller
authors.affiliation: 3Otsuka Pharmaceutical Development & Commercialization Inc.,Princeton,NJ,USA.
authors.forename: Catherine
authors.initials: C
authors.lastname: Weiss
authors.affiliation: 3Otsuka Pharmaceutical Development & Commercialization Inc.,Princeton,NJ,USA.
authors.forename: Mary
authors.initials: M
authors.lastname: Hobart
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D013876:Thiophenes / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D015363:Quinolones; D013876:Thiophenes; C000591922:brexpiprazole
keywords: PANSS; efficacy; maintenance; safety; schizophrenia