Otsuka Pharmaceutical Co. and Lundbeck recently announced initiation of patient enrollment for two global phase 3 clinical trials of Rexulti for treatment of manic episodes associated with bipolar I disorder.
The FDA approved Rexulti (brexpiprazole) in July 2015 for treatment of schizophrenia and as an adjunctive treatment for major depressive disorder.
According to a press release, the phase 3 trials will assess efficacy and safety of brexpiprazole among patients with bipolar I disorder experiencing an acute manic episode, with or without mixed features, that requires hospitalization.
The multicenter, randomized, double-blind studies will compare brexpiprazole with placebo with a primary endpoint of mean change in Young-Mania Rating Scale total scores from baseline to day 21.
The secondary endpoint will be change in Clinical Global Impression-Bipolar severity-of-illness scores in mania from baseline to day 21.
Safety and tolerability will also be measured.