
Lundbeck and Otsuka’s bipolar treatment fails Phase 3 trials due to unexpected placebo effect
pharmafile | February 15, 2019 | News story | Medical Communications | CNS, Lundbeck, Otsuka, Rexulti, bipolar disorder, mental health
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.
The studied did not perform better than placebos as measured by the Young Mania Rating Scale (YMRS). In both studies placebo performed substantially higher than anticipated.
Brexpiprazole was generally well tolerated during trials. The failure of trials in bipolar I disorder do not have any bearing on brexpiprazole’s use a treatment for major depressive disorder (MDD) or schizophrenia.
Louis Goss
Related Content

Men’s health – a new report from the Department of Health and Social Care
The UK Department of Health and Social Care has published a new report entitled Men’s …

Five Facts about men’s mental health
1 While only 15.4% of men are diagnosed with a common mental health condition (CMHC’s) …

Five Facts about sleep and mental health
1 Rapid Eye Movement (REM) sleep enhances creative thinking and helps the brain form connections …






