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.

大冢制药有限公司（Otsuka）宣布，它已经在日本获得了Rexulti（通用名：brexpiprazole）额外治疗适应症的监管批准，该适应症被描述为治疗“由于阿尔茨海默氏病引起的痴呆症引起的情绪，烦躁和/或爆发的快速变化而导致的过度运动或身体/言语攻击行为。”该药物在日本获得批准的适应症已在美国获得批准。

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.

以及其他被称为“阿尔茨海默病引起的痴呆症相关的激动症状”的国家这是Rexulti在日本接受的第三种治疗适应症，除了精神分裂症和重度抑郁症的辅助治疗外。日本的3期临床试验评估了brexpiprazole（1mg/天和2mg/天口服片剂）与安慰剂在10周内治疗410名年龄在55至90岁的成年患者的疗效和安全性，这些患者因阿尔茨海默氏病引起的痴呆症引起的躁动。

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.

该研究的主要终点已经达到，表明与安慰剂组相比，服用1mg/天或2mg/天的brexpiprazole组的Cohen-Mansfield激动量表（CMAI）总分有统计学显着改善。与安慰剂组相比，1mg/天和2mg/天brexpiprazole组的临床总体印象严重程度疾病（CGI-S）评分等次要终点也有改善。

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.

Brexpiprazole通常耐受性良好，没有观察到新的安全信号。大冢制药总裁兼代表董事井上真男评论道：“大冢制药的目标是成为一家全面的医疗保健公司，不仅为身心健康，而且为整个人提供解决方案。