Otsuka, Lundbeck initiate phase 3 trials of Rexulti for bipolar I disorder

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.

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.