Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed labeling update of Rexulti (brexpiprazole) for the maintenance treatment of adults with schizophrenia.
The sNDA submission is based on data from a 52-week randomized withdrawal trial in adults with schizophrenia. Patients were stabilized on Rexulti, and then randomized to either continue treatment with Rexulti (1−4 mg/day) or receive placebo. The primary endpoint was time from randomization to relapse.
Interim results showed that patients treated with Rexulti demonstrated a statistically significantly longer time to relapse compared to placebo-treated patients. The trial was terminated early because maintenance of efficacy had been demonstrated (P<0.0001).
The FDA has set an action date of September 23, 2016 for the sNDA under the Prescription Drug User Fee Act (PDUFA).
Rexulti is an atypical antipsychotic currently approved as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia.