Brexpiprazole fails in manic episodes associated with bipolar 1 disorder

Danish CNS specialist Lundbeck (LUND: CO) saw its shares drop as much as 4% to 275.60 kroner today, after it released disappointing clinical results for its already marketed drug Rexulti (brexpiprazole).

Along with partner Japan’s Otsuka Pharmaceutical (TYO: 4578), Lundbeck today announced that data from two global Phase III clinical trials evaluating the safety and efficacy of brexpiprazole for the treatment of patients with manic episodes associated with bipolar I disorder did not meet the primary endpoint. The duration of the randomized phase of each trial was three weeks.

The two multicenter, randomized, double-blind studies of brexpiprazole versus placebo comprised a total of approximately 650 bipolar I patients who experienced an acute manic episode, with or without mixed features, that required hospitalization. The primary efficacy measure to assess the psychiatric signs and symptoms was determined using the Young Mania Rating Scale (YMRS). The YMRS score is a widely-used clinician rating scale to assess mania symptoms based on a patient’s subjective reports of their condition and clinical observations made during interviews.i