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Psych Congress  

Efficacy of brexpiprazole (OPC-34712) on PANSS items and Marder Factor scores: a meta-analysis of two pivotal studies in schizophrenia

Authors  
Catherine Weiss, PhD
Stephen R. Marder, MD
Aleksandar Skuban, MD
John Ouyang, PhD
Emmanuelle Weiller, PsyD
Sponsor  
Otsuka and Lundbeck

Background: Brexpiprazole, a serotonin-dopamine activity modulator, is a partial agonist at serotonin 5-HT1A and dopamine D2 receptors at similar potency, and antagonist at serotonin 5-HT2A and noradrenaline alpha1B/2C receptors. This post-hoc analysis evaluated efficacy of brexpiprazole across a spectrum of schizophrenia symptoms using five validated PANSS-derived Marder factor scores: positive, negative, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression. Methods: Analysis was performed on pooled data from two pivotal, 6-week, double-blind, placebo-controlled studies of patients with schizophrenia, randomly assigned to once-daily fixed doses of brexpiprazole 2 mg (n=359), 4 mg (n=359) or placebo (n=358) (NCT01396421; NCT01393613). Brexpiprazole efficacy on PANSS total score, PANSS-derived Marder factor scores, and PANSS single items was evaluated. Change from baseline at week 6 for all data was analyzed using mixed model repeated measures with fixed study effects. Results: Pooled brexpiprazole data were superior to placebo in PANSS total score (least square mean difference [LSMD] versus placebo: -6.69, p<0.0001 and -5.46, p=0.0004, respectively). LSMD versus placebo was significant (p<0.05) for brexpiprazole on all Marder factor scores. On PANSS single items, LSMD versus placebo was significant (P<0.05) on 22/30 items for brexpiprazole 4 mg and 13/30 items for brexpiprazole 2 mg. There were no common TEAEs (≥5% and twice the rate of placebo). Conclusion: Results from this analysis demonstrated consistent efficacy of brexpiprazole (4 mg and 2 mg), across the spectrum of symptoms associated with schizophrenia. However, improvements in psychopathological domains that occur during treatment of acute psychosis may be secondary to improvement in psychosis. Brexpiprazole was well tolerated.

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