Lundbeck and Otsuka’s bipolar treatment fails Phase 3 trials due to unexpected placebo effect
Lundbeck and Otsuka’s treatment for bipolar disorder, Rexulti, failed to achieve its primary endpoint in two separate Phase 3 trials.
Brexpiprazole (Rexulti) did not meet its primary endpoint in two three-week, double-blind, placebo-controlled Phase 3 trials as a treatment for patients with manic episodes associated with bipolar I disorder.
The two trials involved around 650 bipolar I patients who had experienced an acute manic episode that required hospitalisation.
The studied did not perform better than placebos as measured by the Young Mania Rating Scale (YMRS). In both studies placebo performed substantially higher than anticipated.
Brexpiprazole was generally well tolerated during trials. The failure of trials in bipolar I disorder do not have any bearing on brexpiprazole’s use a treatment for major depressive disorder (MDD) or schizophrenia.
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