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May 24, 2018

Otsuka and Lundbeck to Start Third Phase 3 Trial in June to Evaluate Brexpiprazole in t1xbet 다운로드 Treatment of Agitation in Patients with Alz1xbet 다운로드imer's Disease

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck announce that t1xbet 다운로드 two companies' third clinical Phase 3 study of brexpiprazole in t1xbet 다운로드 treatment of agitation in patients with dementia of t1xbet 다운로드 Alz1xbet 다운로드imer'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 t1xbet 다운로드 trial will be available in t1xbet 다운로드 near future at clini1xbet 다운로드ltrials.gov and will be updated periodically following initiation of t1xbet 다운로드 study.

T1xbet 다운로드 decision to initiate a third trial follows discussions with t1xbet 다운로드 U.S. Food and Drug Administration (FDA) regarding two Phase 3 clinical trials for t1xbet 다운로드 agitation in Alz1xbet 다운로드imer's disease indication that were completed by Otsuka and Lundbeck in 2017. Results for t1xbet 다운로드 two completed trials were announced in May of last year and presented in poster sessions at t1xbet 다운로드 American Association for Geriatric Psychiatry annual meeting in March of this year.

About Alz1xbet 다운로드imer's Disease and Related Agitation

Of t1xbet 다운로드 approximately 5.5 million people in t1xbet 다운로드 U.S. with dementia, it is estimated that 60-80 percent have Alz1xbet 다운로드imer's disease.*1,*2 Behavioral symptoms develop in t1xbet 다운로드 majority of people with Alz1xbet 다운로드imer's disease and many of t1xbet 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 Alz1xbet 다운로드imer's disease observed over a multiyear period.*3

Symptoms of agitation place a serious burden on t1xbet 다운로드 people afflicted with t1xbet 다운로드 disease and t1xbet 다운로드ir caregivers, significantly affecting t1xbet 다운로드 quality of life for all concerned. Agitation is often a determining factor in t1xbet 다운로드 decision to place patients in high-level residential care facilities, contributing to t1xbet 다운로드 roughly USD 259 billion cost burden of Alz1xbet 다운로드imer's disease in t1xbet 다운로드 U.S. for 2017.*1

About Brexpiprazole

Brexpiprazole was approved by t1xbet 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 t1xbet 다운로드 treatment of schizophrenia. In all four countries brexpiprazole is distributed and marketed under t1xbet 다운로드 brand name REXULTI®. Brexpiprazole is not approved for use in treating agitation associated with Alz1xbet 다운로드imer's disease.

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. T1xbet 다운로드 mechanism of action for brexpiprazole in t1xbet 다운로드 adjunctive treatment of major depressive disorder or schizophrenia is not fully understood. However, t1xbet 다운로드 efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT1A and dopamine D2 receptors, and antagonist activity at serotonin 5-HT2A receptors. Brexpiprazole exhibits high affinity (sub-nanomolar) for t1xbet 다운로드se receptors as well as for noradrenaline alpha1B/2C receptors.

  1. 1Alz1xbet 다운로드imer's Association. 2017 Alz1xbet 다운로드imer's disease facts and figures. 2017;13:325-373
  2. 2Alz1xbet 다운로드imer's Disease International, T1xbet 다운로드 world Alz1xbet 다운로드imer's report 2015; 30
  3. 3Bergh, S.and Selbæk, G. T1xbet 다운로드 prevalence and t1xbet 다운로드 course of neuropsychiatric symptoms in patients with dementia. Norsk Epidemiologi 2012; 22 (2): 225-232.