Data from two Phase 3 studies evaluating brexpiprazole for the treatment of patients with manic episodes associated with bipolar I disorder did not meet the primary endpoint of statistical separation from placebo as measured by the Young Mania Rating Scale (YMRS) at week 3.

The 2 multicenter, randomized, double-blind trials compared brexpiprazole to placebo in ~650 patients (aged 18 to 65 years) with bipolar I disorder who had an acute manic episode, with or without mixed features, that required hospitalization or treatment with a mood stabilizer or an antipsychotic agent. The primary measure of efficacy was a statistically significant improvement determined by YMRS score, a rating scale used to assess mania symptoms.  

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Results at 3 weeks showed that in both studies, statistical separation from placebo was not observed. In addition, the researchers noted the placebo effect was substantially higher than anticipated. With regard to safety, the most common adverse events reported were akathisia and headache; the treatment was generally well-tolerated in both studies. Based on these results, Lundbeck and Otsuka plan on doing a thorough analysis of the study data to determine next steps.

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Brexpiprazole (Rexulti) is currently approved by the Food and Drug Administration as an adjunct to antidepressants in major depressive disorder (MDD) and for the treatment of schizophrenia. Its mechanism of action is thought to be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors.

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