Lundbeck, Otsuka's brexpiprazole misses in Phase III for bipolar I disorder

H. Lundbeck A/S (CSE:LUN) and Otsuka Pharmaceutical Co. Ltd. (Tokyo, Japan) said brexpiprazole missed the primary endpoints in two Phase III trials to treat manic episodes associated with bipolar I disorder. The partners will evaluate the data to determine next steps.

In a total of 655 patients, oral brexpiprazole failed to significantly improve psychiatric signs and symptoms as measured by the change from baseline in Young Mania Rating Scale (YMRS) score from baseline to three weeks vs. placebo. The partners said there was a substantially higher placebo effect than anticipated...