FDA approves label update on maintenance treatment of schizophrenia- Lundbeck/Otsuka

Lundbeck and Otsuka announced that the FDA has 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.

The safety and efficacy of Rexulti as maintenance treatment in adults with schizophrenia aged 18 to 65 years were demonstrated in a long-term randomized withdrawal trial. A pre-specified interim analysis conducted after about 50% of the expected 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 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.

Comment: Lundbeck and Otsuka anticipate submitting a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for the use of brexpiprazole in the treatment of adult patients with schizophrenia.