Otsuka Pharmaceutical Co., Ltd. and H. Lundbeck A/S said the U.S. Food and Drug Administration approved REXULTI (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder or MDD and as a treatment for adults with schizophrenia.
REXULTI was discovered by Otsuka and co-developed with Lundbeck. It will be co-marketed by the two companies and is expected to become available to patients in the U.S. in early August.
The mechanism of action of REXULTI in the treatment of MDD or schizophrenia is not known. It was studied in more than 4,300 subjects in phase II and III clinical trials.
The approval was supported by four completed placebo-controlled clinical phase III studies in the now-approved indications.
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