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:® https://www.otsuka-us.com/discover/us-fda-approves-labeling-update-of-rexulti-brexpiprazole-for-maintenance-treatment-of-schizophrenia

The release as fetched from its publisher. otsuka.co.jp ↗