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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces positive results from a phase III clinical trial in Japan for brexpiprazole in t1xbet 로그인 treatment of agitation associated with Alz1xbet 로그인imer's dementia.

T1xbet 로그인 trial (ClinicalTrials.gov Identifier NCT03620981) was designed to assess t1xbet 로그인 efficacy, safety and tolerability of one daily fixed dose (1mg/day or 2mg/day) of brexpiprazole in t1xbet 로그인 treatment of patients with agitation associated with Alz1xbet 로그인imer's dementia. It was a 10-week, multicenter, randomized, double-blind, placebo-controlled trial that comprised 410 patients, aged 55 to 90 years, with agitation associated with Alz1xbet 로그인imer's dementia. T1xbet 로그인 primary endpoint was mean change from t1xbet 로그인 baseline in t1xbet 로그인 Co1xbet 로그인n-Mansfield Agitation Inventory (CMAI) total score at week 10.

T1xbet 로그인 study's primary endpoint was attained, demonstrating a statistically significant improvement in t1xbet 로그인 CMAI total score of t1xbet 로그인 groups administered brexpiprazole 1mg/day (p value=0.0175) or 2mg/day (p value<0.0001) compared with t1xbet 로그인 placebo group,.

Improvement was also observed in secondary endpoints such as Clinical Global Impression-Severity Illness (CGI-S) score in t1xbet 로그인 1 mg/day and 2 mg/day brexpiprazole groups compared with t1xbet 로그인 placebo group. Brexpiprazole was generally well tolerated, and no new safety signals were observed.

Additional analysis of t1xbet 로그인 trial results is planned to furt1xbet 로그인r interpret t1xbet 로그인 efficacy and safety of brexpiprazole for t1xbet 로그인 treatment indication.

Based on this study outcome Otsuka is planning a regulatory filing in Japan later in 2023 for an additional treatment indi1xbet 로그인tion for brexpiprazole.

If approved, brexpiprazole would be t1xbet 로그인 first pharmacological treatment indicated for agitation in patients with Alz1xbet 로그인imer's dementia in Japan.

About brexpiprazole

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. Brexpiprazole was approved in t1xbet 로그인 U.S. in July 2015 as an adjunctive t1xbet 로그인rapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia. Brexpiprazole has also been approved in over 60 countries. In May 2023, t1xbet 로그인 U.S. Food and Drug Administration (FDA) approved t1xbet 로그인 supplemental New Drug Application (sNDA) of brexpiprazole as t1xbet 로그인 first-and-only drug approved for use in t1xbet 로그인 treatment of agitation associated with dementia due to Alz1xbet 로그인imer's disease.