January 6, 2017
Otsuka Pharmaceutical Co., Ltd.
Otsuka Submits New Drug Application in Japan for Brexpiprazole in the Treatment of Schizophrenia
Otsuka Pharmaceutical Co., Ltd. today announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare for the manufacture and sale in Japan of brexpiprazole in the treatment of schizophrenia.
Brexpiprazole is a serotonin-dopamine activity modulator (SDAM) that acts as a partial agonist at 5-HT1A and dopamine D2 receptors, and an antagonist at 5-HT2A and noradrenaline alpha1B/2C receptors.
Brexpiprazole was discovered by Otsuka and is in global co-development with the Danish company Lundbeck. This drug was approved in the U.S. by the Food and Drug Administration in July 2015 for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD). It was launched there in August 2015 with the brand name "REXULTI®".
Information in this news release was current as of the original release date.