Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has filed an application in Japan for an additional indication for Rexulti^® (generic name: brexpiprazole) in the treatment of agitation associated with dementia　due to Alzheimer's disease. If approved, brexpiprazole would be the first pharmacological treatment indicated for agitation in patients with dementia　due to Alzheimer's disease in Japan.

The phase 3 clinical trial in Japan evaluated the efficacy and safety of brexpiprazole (1mg/day and 2mg/day) versus placebo over ten weeks in the treatment of 410 adult patients aged 55 to 90 with agitation associated with dementia　due to Alzheimer's disease. The study's primary endpoint was attained, demonstrating a statistically significant improvement in the Cohen-Mansfield Agitation Inventory (CMAI) total score of the groups administered brexpiprazole 1mg/day or 2mg/day compared with the placebo group. Improvement was also observed in secondary endpoints such as the Clinical Global Impression-Severity Illness (CGI-S) score in the 1mg/day and 2mg/day brexpiprazole groups compared with the placebo group. Brexpiprazole was generally well tolerated, and no new safety signals were observed.

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