FDA accepts to review supplemental New Drug Application for Rexulti for schizophrenia
Otsuka Pharmaceutical Co. Ltd, and Lundbeck recently announced the FDA accepted for review a supplemental New Drug Application for Rexulti for maintenance treatment of schizophrenia in adults.
The FDA is expected to complete the review of the expanded labeling of Rexulti (brexpiprazole, Otsuka), by Sept. 23, 2016.
Rexulti was approved by the FDA for treatment of schizophrenia in adults and as adjunctive treatment for major depressive disorder in adults in July 2015.
Results from a 52-week randomized withdrawal trial in adults with schizophrenia support the supplemental New Drug Application.
Study participants were stabilized on brexpiprazole and then randomized to continued therapy with 1 mg to 4 mg per day of brexpiprazole (n = 96) or placebo (n = 104).
Individuals who received brexpiprazole exhibited statistically significantly longer time to relapse compared with those who received placebo.
Adverse reactions reported during the maintenance phase were similar to those reported in the short-term schizophrenia trials.
The trial was terminated early because maintenance of efficacy had been demonstrated, according to a company press release.