Otsuka Pharmaceutical Co., Ltd.

September 26, 2016

U.S. FDA Approves Labeling Update of REXULTI®(brexpiprazole) for Maintenance Treatment of Schizophrenia in Patients in the U.S.

  • Labeling update includes clinical data on use of REXULTI in adult patients with schizophrenia in the maintenance phase of treatment
  • Approval was based on REXULTI demonstrating efficacy and safety in a long-term randomized withdrawal trial
  • The trial demonstrated a statistically significant (p < 0.0001) longer time to relapse in patients treated with REXULTI compared to placebo-treated patients

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and H. Lundbeck A/S (Lundbeck) announced today 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 in patients in the U.S. The approval was based on results from a long-term randomized withdrawal trial in adults with schizophrenia aged 18 to 65 years.

For additional information on the clinical trial results please refer to the announcement by OPDC here: