Label update for Rexulti (brexpiprazole) filed with FDA for the maintenance treatment of adults with schizophrenia- Lundbeck and Otsuka

The FDA has accepted for review a supplemental New Drug Application (sNDA) for the proposed labeling update of Rexulti (brexpiprazole), from Lundbeck and Otsuka, for the maintenance treatment of adults with schizophrenia. Under the Prescription Drug User Fee Act (PDUFA), the PDUFA date is 23 September 2016. Rexulti was approved by the FDA in July 2015 as a treatment for adults with schizophrenia and as an adjunctive treatment for adults with major depressive disorder (MDD).

The sNDA is supported by results from a 52-week randomized withdrawal trial in adults with schizophrenia aged 18 to 65 years. In the trial, patients were stabilized on Rexulti and were then randomized to continued therapy with Rexulti (n=96) or placebo (n=104). The primary endpoint of the study was time from randomization to relapse. At a pre-specified interim analysis, the study demonstrated a statistically significantly longer time to relapse in patients randomized to the Rexulti group (1 mg/day to 4 mg/day) compared to placebo-treated patients and the trial was terminated early because maintenance of efficacy had been demonstrated (p < 0.0001, final analysis). During the randomized maintenance phase, adverse reactions were similar to those reported in the short-term schizophrenia trials.