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.

Advertisement

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

FDA signals support for development of psychedelic therapies in mental healthmental health

The US Food and Drug Administration (FDA) has announced a series of measures aimed at …

Stage4You encourages stage 4 bowel cancer patients to prioritise mental health ahead of Bowel Cancer Awareness Month

Stage4You, a campaign funded and developed by Takeda UK and supported by Bowel Cancer UK, …

Historic UN declaration supporting mental health – treatment to be given similar priority to chronic diseases

The 80th United Nations General Assembly (UNGA) has adopted the political declaration to combat mental …

The Gateway to Local Adoption Series

Latest content