TOKYO, JAPAN & MONTREAL, QC-Otsuka Pharmaceutical Co. and Lundbeck Canada announce that Health Canada has issued a Notice of Compliance for REXULTI™ (brexpiprazole) for the treatment of schizophrenia in adults.
REXULTI™ was discovered by Otsuka and co-developed with Lundbeck. It will be co-marketed by the two companies and is expected to become commercially available in Canada this spring.
REXULTI™ was studied in more than 2700 subjects with schizophrenia in Phase 2 and 3 clinical trials, and the approval was supported by three completed placebo-controlled clinical Phase 3 studies in the now-approved indication.
In clinical trials, REXULTI™ was found to significantly improve both positive and negative symptoms. It is given in a once-daily oral dose with a well-defined titration schedule that can be taken with or without food.