Pharmamarketeer

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.

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