Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has obtained regulatory approval in Japan on an additional treatment indication for Rexulti (generic name: brexpiprazole), described as treatment of "excessive motor activity or physically/verbally aggressive behavior due to rapid changes in mood, irritability, and/or outbursts associated with dementia due to Alzheimer's disease." The indication for which the drug has been approved in Japan has been approved in the U.S. and other countries under the description "agitation symptoms associated with dementia due to Alzheimer's disease." This is the third treatment indication received by Rexulti in Japan, in addition to schizophrenia and adjunctive treatment of major depressive disorder.

The phase 3 clinical trial in Japan evaluated the efficacy and safety of brexpiprazole (1mg/day and 2mg/day oral tablets) versus placebo over 10 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.

Makoto Inoue, president and representative director of Otsuka Pharmaceutical commented, "Otsuka Pharmaceutical aims to be a total healthcare company that provides solutions not only for physical and mental health, but also for the entire society surrounding people. In Japan, where the population is aging at an accelerating rate, the addition of this additional Rexulti treatment indication is expected to be an important turning point for both patients with Alzheimer's disease and their caregivers. Otsuka Pharmaceutical will continue its efforts to provide comprehensive options for the wellbeing of patients and their families and caregivers.

About Rexulti (brexpiprazole)

Brexpiprazole was approved in the U.S. in 2015, as an adjunctive therapy to antidepressants in adults with MDD (major depressive disorder) and as a treatment for schizophrenia in adults. It was approved in 2018 by the European Medicines Agency and by the Ministry of Health, Labour and Welfare (MHLW) in Japan for the treatment of schizophrenia and in 2023 by the MHLW as an adjunctive treatment for MDD.

In May 2023 brexpiprazole was approved in the U.S. for the treatment of agitation associated with dementia due to Alzheimer's disease. As of August 2024, the indication for "agitation associated with dementia due to Alzheimer's disease " has been approved also in Canada, the Philippines, and Taiwan.