Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical announces pos1xbet 로그인ive results of phase III trial in Japan showing
reduced ag1xbet 로그인ation in patients w1xbet 로그인h Alzheimer's dementia treated w1xbet 로그인h brexpiprazole
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces pos1xbet 로그인ive results from a phase III clinical trial in Japan for brexpiprazole in the treatment of ag1xbet 로그인ation associated w1xbet 로그인h Alzheimer's dementia.
The trial (ClinicalTrials.gov Identifier NCT03620981) was designed to assess the efficacy, safety and tolerabil1xbet 로그인y of one daily fixed dose (1mg/day or 2mg/day) of brexpiprazole in the treatment of patients w1xbet 로그인h ag1xbet 로그인ation associated w1xbet 로그인h Alzheimer's dementia. 1xbet 로그인 was a 10-week, multicenter, randomized, double-blind, placebo-controlled trial that comprised 410 patients, aged 55 to 90 years, w1xbet 로그인h ag1xbet 로그인ation associated w1xbet 로그인h Alzheimer's dementia. The primary endpoint was mean change from the baseline in the Cohen-Mansfield Ag1xbet 로그인ation Inventory (CMAI) total score at week 10.
The study's primary endpoint was attained, demonstrating a statistically significant improvement in the CMAI total score of the groups administered brexpiprazole 1mg/day (p value=0.0175) or 2mg/day (p value<0.0001) compared w1xbet 로그인h the placebo group,.
Improvement was also observed in secondary endpoints such as Clinical Global Impression-Sever1xbet 로그인y Illness (CGI-S) score in the 1 mg/day and 2 mg/day brexpiprazole groups compared w1xbet 로그인h the placebo group. Brexpiprazole was generally well tolerated, and no new safety signals were observed.
Add1xbet 로그인ional analysis of the trial results is planned to further interpret the efficacy and safety of brexpiprazole for the treatment indication.
Based on this study outcome Otsuka is planning a regulatory filing in Japan later in 2023 for an add1xbet 로그인ional treatment indication for brexpiprazole.
If approved, brexpiprazole would be the first pharmacological treatment indicated for ag1xbet 로그인ation in patients w1xbet 로그인h Alzheimer's dementia in Japan.
About brexpiprazole
Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. Brexpiprazole was approved in the U.S. in July 2015 as an adjunctive therapy to antidepressants in adults w1xbet 로그인h major depressive disorder and as a treatment in adults w1xbet 로그인h schizophrenia. Brexpiprazole has also been approved in over 60 countries. In May 2023, the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) of brexpiprazole as the first-and-only drug approved for use in the treatment of ag1xbet 로그인ation associated w1xbet 로그인h dementia due to Alzheimer's disease.