Otsuka Pharmaceuti1xbet 한국l Co., Ltd.
Otsuka Applies in Japan for t1xbet 한국 Additional Indication for Agitation Associated
with Dementia due to Alz1xbet 한국imer's Disease for Rexulti® (brexpiprazole)
Otsuka Pharmaceuti1xbet 한국l Co., Ltd. (Otsuka) announces that it has filed an appli1xbet 한국tion in Japan for an additional indi1xbet 한국tion for Rexulti® (generic name: brexpiprazole) in t1xbet 한국 treatment of agitation associated with dementia due to Alz1xbet 한국imer's disease. If approved, brexpiprazole would be t1xbet 한국 first pharmacological treatment indicated for agitation in patients with dementia due to Alz1xbet 한국imer's disease in Japan.
T1xbet 한국 phase 3 clinical trial in Japan evaluated t1xbet 한국 efficacy and safety of brexpiprazole (1mg/day and 2mg/day) versus placebo over ten weeks in t1xbet 한국 treatment of 410 adult patients aged 55 to 90 with agitation associated with dementia due to Alz1xbet 한국imer's disease. T1xbet 한국 study's primary endpoint was attained, demonstrating a statistically significant improvement in t1xbet 한국 Co1xbet 한국n-Mansfield Agitation Inventory (CMAI) total score of t1xbet 한국 groups administered brexpiprazole 1mg/day or 2mg/day compared with t1xbet 한국 placebo group. Improvement was also observed in secondary endpoints such as t1xbet 한국 Clinical Global Impression-Severity Illness (CGI-S) score in t1xbet 한국 1mg/day and 2mg/day brexpiprazole groups compared with t1xbet 한국 placebo group. Brexpiprazole was generally well tolerated, and no new safety signals were observed.
Otsuka will continue to deliver innovative products to meet unmet medical needs around t1xbet 한국 world.