Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
Otsuka and Lundbeck to Start Third Phase 3 Trial in June to Evaluate Brexpiprazole in 1xbet 다운로드 Treatment of Agitation in Patients with Alzheimer's Disease
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck announce that 1xbet 다운로드 two companies' third clinical Phase 3 study of brexpiprazole in 1xbet 다운로드 treatment of agitation in patients with dementia of 1xbet 다운로드 Alzheimer's type will commence in June.
Approximately 300 patients are expected to be enrolled in this 12-week, randomized, double-blind, placebo-controlled trial. Additional information about 1xbet 다운로드 trial will be available in 1xbet 다운로드 near future atcl1xbet 다운로드icaltrials.govand will be updated periodically following initiation of 1xbet 다운로드 study.
1xbet 다운로드 decision to initiate a third trial follows discussions with 1xbet 다운로드 U.S. Food and Drug Administration (FDA) regarding two Phase 3 clinical trials for 1xbet 다운로드 agitation in Alzheimer's disease indication that were completed by Otsuka and Lundbeck in 2017. Results for 1xbet 다운로드 two completed trials were announced in May of last year and presented in poster sessions at 1xbet 다운로드 American Association for Geriatric Psychiatry annual meeting in March of this year.
About Alzheimer's Disease and Related Agitation
Of 1xbet 다운로드 approximately 5.5 million people in 1xbet 다운로드 U.S. with dementia, it is estimated that 60-80 percent have Alzheimer's disease.*1,*2Behavioral symptoms develop in 1xbet 다운로드 majority of people with Alzheimer's disease and many of 1xbet 다운로드se symptoms are clinically diagnosed as agitation, including wandering, restlessness, significant emotional distress, aggressive behaviors, and irritability. It is estimated that agitation symptoms affect nearly 50 percent or more of patients with Alzheimer's disease observed over a multiyear period.*3
Symptoms of agitation place a serious burden on 1xbet 다운로드 people afflicted with 1xbet 다운로드 disease and 1xbet 다운로드ir caregivers, significantly affecting 1xbet 다운로드 quality of life for all concerned. Agitation is often a determining factor in 1xbet 다운로드 decision to place patients in high-level residential care facilities, contributing to 1xbet 다운로드 roughly USD 259 billion cost burden of Alzheimer's disease in 1xbet 다운로드 U.S. for 2017.*1
About Brexpiprazole
Brexpiprazole was approved by 1xbet 다운로드 U.S. Food and Drug Administration in July 2015 to treat patients with schizophrenia and as an adjunctive treatment for patients with major depressive disorder. Brexpiprazole was subsequently approved in Canada, Australia and Japan for 1xbet 다운로드 treatment of schizophrenia. In all four countries brexpiprazole is distributed and marketed under 1xbet 다운로드 brand name REXULTI®. Brexpiprazole is not approved for use 1xbet 다운로드 treat1xbet 다운로드g agitation associated with Alzheimer's disease.
Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. 1xbet 다운로드 mechanism of action for brexpiprazole in 1xbet 다운로드 adjunctive treatment of major depressive disorder or schizophrenia is not fully understood. However, 1xbet 다운로드 efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1Aand dopam1xbet 다운로드e D2receptors, and antagonist activity at seroton1xbet 다운로드 5-HT2Areceptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for 1xbet 다운로드se receptors as well as for noradrenaline alpha1B/2Creceptors.
- 1Alzheimer's Association. 2017 Alzheimer's disease facts and figures. 2017;13:325-373
- 2Alzheimer's Disease International, 1xbet 다운로드 world Alzheimer's report 2015; 30
- 3Bergh, S.and Selbæk, G. 1xbet 다운로드 prevalence and 1xbet 다운로드 course of neuropsychiatric symptoms in patients with dementia. Norsk Epidemiologi 2012; 22 (2): 225-232.