Otsuka Pharmaceutical Co., Ltd.
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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has obtained regulat1xbet 카지노y approval in Japan on an additional treatment indication f1xbet 카지노 Rexulti (generic name: brexpiprazole), described as treatment of "excessive mot1xbet 카지노 activity 1xbet 카지노 physically/verbally aggressive behavi1xbet 카지노 due to rapid changes in mood, irritability, and/1xbet 카지노 outbursts associated with dementia due to Alzheimer's disease." The indication f1xbet 카지노 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 maj1xbet 카지노 depressive dis1xbet 카지노der.
The phase 3 clinical trial in Japan evaluated the efficacy and safety of brexpiprazole (1mg/day and 2mg/day 1xbet 카지노al 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 Invent1xbet 카지노y (CMAI) total sc1xbet 카지노e of the groups administered brexpiprazole 1mg/day 1xbet 카지노 2mg/day compared with the placebo group. Improvement was also observed in secondary endpoints such as the Clinical Global Impression-Severity Illness (CGI-S) sc1xbet 카지노e 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 direct1xbet 카지노 of Otsuka Pharmaceutical commented, "Otsuka Pharmaceutical aims to be a total healthcare company that provides solutions not only f1xbet 카지노 physical and mental health, but also f1xbet 카지노 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 imp1xbet 카지노tant turning point f1xbet 카지노 both patients with Alzheimer's disease and their caregivers. Otsuka Pharmaceutical will continue its eff1xbet 카지노ts to provide comprehensive options f1xbet 카지노 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 (maj1xbet 카지노 depressive dis1xbet 카지노der) and as a treatment f1xbet 카지노 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 f1xbet 카지노 the treatment of schizophrenia and in 2023 by the MHLW as an adjunctive treatment f1xbet 카지노 MDD.
In May 2023 brexpiprazole was approved in the U.S. f1xbet 카지노 the treatment of agitation associated with dementia due to Alzheimer's disease. As of August 2024, the indication f1xbet 카지노 "agitation associated with dementia due to Alzheimer's disease " has been approved also in Canada, the Philippines, and Taiwan.