Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and H. Lundbeck A/S (Lundbeck) have announced that the U.S. Food and Drug Administration (FDA) approved the labeling update of REXULTI® (brexpiprazole) to reflect clinical data for maintenance treatment of schizophrenia. The approval was based on results from a long-term randomized withdrawal trial in adults with schizophrenia aged 18 to 65 years.
“There are approximately 2.4 million adults in the U.S. with schizophrenia1 and 75% of patients2 experience relapses where their symptoms return or worsen,” said Dr. Christoph U. Correll, professor of psychiatry, Hofstra Northwell School of Medicine and medical director, Recognition and Prevention Program (RAP), Zucker Hillside Hospital, both in New York. “These data, as included in the product labeling, confirm the utility of REXULTI in the maintenance treatment of patients with schizophrenia in order to help delay the time to relapse, giving patients and their physicians new data to consider when selecting an antipsychotic.”
The safety and efficacy of REXULTI as maintenance treatment in adults with schizophrenia aged 18 to 65 years was demonstrated in a long-term randomized withdrawal trial. After cross-titration from a prior antipsychotic to REXULTI, and a 12-to 36-week, single-blind REXULTI stabilization phase, patients who had been symptomatically stable on REXULTI for 12 consecutive weeks in the stabilization phase were randomized in a double-blind treatment phase to either REXULTI (n=97) or placebo (n=105). Impending relapse during the double-blind phase was determined if patients met any of the following pre-specified criteria: worsening symptoms defined by changes in PANSS or CGI-I scores; hospitalization for worsening psychotic symptoms; suicidal behavior or; violent/aggressive behavior.
An interim analysis conducted after a pre-specified number of impending relapses (in order to minimize continued exposure to placebo) demonstrated a statistically significant longer time to relapse in patients randomized to REXULTI compared to placebo. The trial was subsequently terminated early because maintenance of efficacy had been demonstrated. The final analysis demonstrated a statistically significant longer time to relapse (hazard ratio: 0.292, p < 0.0001) in patients randomized to REXULTI (1 mg/day to 4 mg/day) compared to placebo. The key secondary endpoint, the proportion of subjects who met the criteria for impending relapse, was statistically significantly lower in REXULTI-treated patients compared with placebo group.