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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.

FDA approves Lundbeck and Otsuka’s Rexulti for depression

Rexulti (brexpiprazole)

Lundbeck and Otsuka have gained a yes vote from the FDA for their jointly-marketed antidepressant, Rexulti.

The US regulator approved the drug as an adjunctive therapy for the treatment of major depressive disorder (MDD) in adults with schizophrenia. As a result of the decision, the companies say Rexulti (brexpiprazole) is expected to become available in the US in early August 2015. 

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