FDA Approves New Schizophrenia, Depression Drug Brexpiprazole

Rexulti (brexpiprazole), from Otsuka and Lundbeck, is approved as a monotherapy in schizophrenia and an adjunct in patients with major depression.

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced today that the U.S. Food and Drug Administration (FDA) approved Rexulti (brexpiprazole) as an adjunctive therapy for the treatment of adults with major depressive disorder (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 2015.

The mechanism of action of Rexulti in the treatment of MDD or schizophrenia is unknown. However, the efficacy of Rexulti may be mediated through a combination of partial agonist activity at serotonin 5-HT1 and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. In addition, Rexulti exhibits high affinity (subnanomolar) for these receptors, as well as for noradrenaline alpha1B/2C receptors

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