11 July 2015 - H. Lundbeck A/S (Lundbeck) and Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced today that the US 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 US 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-HT1A 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[iii].  

Rexulti was studied in more than 4,300 subjects in phase II and III clinical trials, and the approval was supported by four completed placebo-controlled clinical phase III studies in the now-approved indications — two studies as adjunctive therapy to antidepressants in MDD and two studies in schizophrenia.

For more details, go to: https://www.lundbeck.com/global