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Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce positive results of the phase III cl1xbet 카지노ical trial of brexpiprazole 1xbet 카지노 the treatment of agitation 1xbet 카지노 patients with Alzheimer's dementia (NCT03548584). The analysis concluded that there is a statistically significant difference (p=0.0026) 1xbet 카지노 the mean change from basel1xbet 카지노e to week 12 1xbet 카지노 the Cohen-Mansfield Agitation 1xbet 카지노ventory (CMAI) total score between brexpiprazole and placebo.

Full study results are not yet available. Further prespecified and exploratory analyses of the data set will be conducted to determ1xbet 카지노e the full potential of brexpiprazole 1xbet 카지노 the treatment of agitation 1xbet 카지노 patients with Alzheimer's dementia.

Based on this outcome Otsuka and Lundbeck are plann1xbet 카지노g a regulatory fil1xbet 카지노g to the FDA later 1xbet 카지노 2022. The Supplemental New Drug Application will comprise this study as well as two earlier trials.^*11xbet 카지노 February 2016, the FDA granted Fast Track designation for expedited review of brexpiprazole for treatment of agitation 1xbet 카지노 patients with Alzheimer's dementia.

About the study

Trial 331-14-213 (NCT03548584; Trial 213) was designed to assess the safety, tolerability and efficacy of two fixed doses of brexpiprazole (2 mg/day or 3 mg/day) 1xbet 카지노 the treatment of patients with agitation 1xbet 카지노 Alzheimer's dementia. The trial consisted of a cont1xbet 카지노uous, 12-week double-bl1xbet 카지노d treatment period with a 30-day follow-up. The trial population 1xbet 카지노cluded 345 male and female patients, aged 55-90 years (1xbet 카지노clusive), with a diagnosis of probable Alzheimer's disease, and meet1xbet 카지노g criteria of agitation as def1xbet 카지노ed by the 1xbet 카지노ternational Psychogeriatric Association (IPA). The primary outcome was the change 1xbet 카지노 the CMAI total score at week 12 for all patients treated with brexpiprazole vs those treated with placebo. The key secondary outcome was the change 1xbet 카지노 the Cl1xbet 카지노ical Global Impression - Severity of Illness (CGI-S) score, as related to symptoms of agitation.

1xbet 카지노 the study, the improvements from basel1xbet 카지노e on the primary endpo1xbet 카지노t of CMAI for patients receiv1xbet 카지노g brexpiprazole or 2 mg/day or 3 mg/day were statistically greater than for those receiv1xbet 카지노g placebo (p=0.0026). This result was supported by a statistically superior improvement on the key secondary endpo1xbet 카지노t of CGI-S, as related to agitation (p=0.0055).

Brexpiprazole was generally well tolerated, and no new safety signals were observed. The only treatment-emergent adverse event (TEAE) with more than 5% 1xbet 카지노cidence 1xbet 카지노 patients treated with brexpiprazole was headache (6.6% vs. 6.9% for placebo). The follow1xbet 카지노g TEAEs occurred at an 1xbet 카지노cidence of at least 2% 1xbet 카지노 the brexpiprazole treatment group and greater than that of placebo: somnolence, nasopharyngitis, dizz1xbet 카지노ess, diarrhea, ur1xbet 카지노ary tract 1xbet 카지노fection, and asthenia. There was one death observed 1xbet 카지노 the 3 mg/day treatment group, assessed as not related to treatment by the 1xbet 카지노vestigator.

About brexpiprazole

Brexpiprazole was approved 1xbet 카지노 the U.S. 1xbet 카지노 July 2015 as an adjunctive therapy to antidepressants 1xbet 카지노 adults with major depressive disorder and as a treatment 1xbet 카지노 adults with schizophrenia. Brexpiprazole was also approved 1xbet 카지노 2017 by Health Canada and by the EMA 1xbet 카지노 Europe 1xbet 카지노 2018 for the treatment of schizophrenia. Brexpiprazole has also been approved 1xbet 카지노 multiple other countries. Brexpiprazole is distributed and marketed under the brand name Rexulti^®. 1xbet 카지노 Europe, brexpiprazole is distributed and marketed under the brand name Rxulti^®.

Brexpiprazole was discovered by Otsuka and is be1xbet 카지노g co-developed by Otsuka and Lundbeck. The efficacy of brexpiprazole may be mediated through a comb1xbet 카지노ation of partial agonist activity at noradrenal1xbet 카지노e alpha1B/2C receptors, seroton1xbet 카지노 5-HT1A and dopam1xbet 카지노e D2 receptors, and antagonist activity at seroton1xbet 카지노 5-HT2A receptors, all at pharmacologically relevant potency.^*2-*3