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Otsuka and Lundbeck report phase III data evaluating brexpiprazole for the treatment of manic episodes associated with bipolar I disorder

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The efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in subjects with bipolar I
disorder was investigated in two three-week, double-blind, placebo-controlled trials
• The studies did not meet the primary endpoint of statistical separation from placebo as measured by the Young Mania Rating
Scale (YMRS) at week 3
• The companies will conduct a thorough analysis of the study results to determine next steps
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce today 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.
The studies did not meet the primary endpoint of statistical separation from placebo as measured by the Young Mania Rating
Scale (YMRS) at week three. In both studies, the placebo effect on the rating scales was substantially higher than anticipated.
Brexpiprazole was generally well tolerated in the trials. The most common adverse reactions observed during the trials were
akathisia (6.5%) and headache (5%) and no other adverse events were greater than 3% for patients receiving brexpiprazole across
the two studies
The companies will conduct a thorough analysis of the study results to determine next steps. The results from the bipolar I
disorder mania studies do not have any bearing on the approved indications of brexpiprazole as treatment for people living with
major depressive disorder (MDD) and schizophrenia.

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