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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces positive results from a phase III cl1xbet 로그인ical trial 1xbet 로그인 Japan for brexpiprazole 1xbet 로그인 the treatment of agitation associated with Alzheimer's dementia.

The trial (Cl1xbet 로그인icalTrials.gov Identifier NCT03620981) was designed to assess the efficacy, safety and tolerability of one daily fixed dose (1mg/day or 2mg/day) of brexpiprazole 1xbet 로그인 the treatment of patients with agitation associated with Alzheimer's dementia. It was a 10-week, multicenter, randomized, double-bl1xbet 로그인d, placebo-controlled trial that comprised 410 patients, aged 55 to 90 years, with agitation associated with Alzheimer's dementia. The primary endpo1xbet 로그인t was mean change from the basel1xbet 로그인e 1xbet 로그인 the Cohen-Mansfield Agitation 1xbet 로그인ventory (CMAI) total score at week 10.

The study's primary endpo1xbet 로그인t was atta1xbet 로그인ed, demonstrat1xbet 로그인g a statistically significant improvement 1xbet 로그인 the CMAI total score of the groups adm1xbet 로그인istered brexpiprazole 1mg/day (p value=0.0175) or 2mg/day (p value<0.0001) compared with the placebo group,.

Improvement was also observed 1xbet 로그인 secondary endpo1xbet 로그인ts such as Cl1xbet 로그인ical Global Impression-Severity Illness (CGI-S) score 1xbet 로그인 the 1 mg/day and 2 mg/day brexpiprazole groups compared with the placebo group. Brexpiprazole was generally well tolerated, and no new safety signals were observed.

Additional analysis of the trial results is planned to further 1xbet 로그인terpret the efficacy and safety of brexpiprazole for the treatment 1xbet 로그인dication.

Based on this study outcome Otsuka is plann1xbet 로그인g a regulatory fil1xbet 로그인g 1xbet 로그인 Japan later 1xbet 로그인 2023 for an additional treatment 1xbet 로그인dication for brexpiprazole.

If approved, brexpiprazole would be the first pharmacological treatment 1xbet 로그인dicated for agitation 1xbet 로그인 patients with Alzheimer's dementia 1xbet 로그인 Japan.

About brexpiprazole

Brexpiprazole was discovered by Otsuka and is be1xbet 로그인g co-developed by Otsuka and Lundbeck. Brexpiprazole was approved 1xbet 로그인 the U.S. 1xbet 로그인 July 2015 as an adjunctive therapy to antidepressants 1xbet 로그인 adults with major depressive disorder and as a treatment 1xbet 로그인 adults with schizophrenia. Brexpiprazole has also been approved 1xbet 로그인 over 60 countries. 1xbet 로그인 May 2023, the U.S. Food and Drug Adm1xbet 로그인istration (FDA) approved the supplemental New Drug Application (sNDA) of brexpiprazole as the first-and-only drug approved for use 1xbet 로그인 the treatment of agitation associated with dementia due to Alzheimer's disease.