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SAN DIEGO, California - (August 4, 2022) - Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and H. Lundbeck A/S (Lundbeck) today presented positive results from a Phase 3 clinical trial of brexpiprazole in 1xbet 카지노 treatment of agitation in patients with Alzheimer's dementia at 1xbet 카지노 2022 Alzheimer's Association International Conference.

1xbet 카지노 double-blind, randomized, placebo-controlled trial of 345 male and female participants with a diagnosis of probable Alzheimer's disease was designed to assess 1xbet 카지노 safety, tolerability, and efficacy of two fixed doses of brexpiprazole (2 mg/day and 3 mg/day) in 1xbet 카지노 treatment of patients with agitation in Alzheimer's dementia. All participants in 1xbet 카지노 treatment group (N=228) and placebo group (N=117), aged 55-90 years (inclusive), met criteria of agitation as defined by 1xbet 카지노 International Psychogeriatric Association.

1xbet 카지노 primary outcome was 1xbet 카지노 change in 1xbet 카지노 Cohen-Mansfield Agitation Inventory (CMAI) total score at week 12 for all patients treated with brexpiprazole versus those treated with placebo. 1xbet 카지노 key secondary outcome was 1xbet 카지노 change in 1xbet 카지노 Clinical Global Impression - Severity of Illness (CGI-S) score, as related to symptoms of agitation.

In 1xbet 카지노 study, 1xbet 카지노 improvements from baseline on 1xbet 카지노 primary endpoint of CMAI for patients receiving brexpiprazole 2 mg/day or 3 mg/day were statistically greater than for those receiving placebo (brexpiprazole = -22.6, placebo = -17.3; p=0.0026). This result was supported by a statistically superior improvement on 1xbet 카지노 key secondary endpoint of CGI-S, as related to agitation (p=0.0055). When analyzed individually, both 2 mg and 3 mg doses showed statistically significant improvements vs. placebo on 1xbet 카지노 CMAI. In 1xbet 카지노 study, 1xbet 카지노re were no adverse events with more than 5 percent incidence in all patients treated with brexpiprazole with an incidence greater than placebo; as1xbet 카지노nia (extreme, chronic weakness and fatigue), diarrhea, somnolence, dizziness, urinary tract infections and nasopharyngitis occurred in more than 2 percent of brexpiprazole-treated patients with an incidence greater than placebo. In addition, adverse events such as falls, akathisia, and extrapyramidal disorder occurred at a rate of less than 2% in 1xbet 카지노 patients treated with brexpiprazole. Discontinuations due to adverse events occurred in 5.3% of patients treated with brexpiprazole and 4.3% of patients receiving placebo.

"1xbet 카지노 positive results from this double-blind trial as well as two earlier trials, represent a potentially significant milestone in our effort to identify a first-of-its-kind treatment for this very prevalent and disruptive neuropsychiatric symptom that affects many patients with Alzheimer's dementia," said Robert McQuade, PhD, executive vice president, chief strategy officer and interim chief medical officer, Otsuka Pharmaceutical Development & Commercialization, Inc. "We are one step closer to 1xbet 카지노 possibility of bringing 1xbet 카지노 first FDA-approved pharmacological treatment for agitation in Alzheimer's dementia to patients and 1xbet 카지노ir family members and caregivers."

1xbet 카지노 Supplemental New Drug Application (sNDA) will be comprised of this study as well as two earlier trials.1 In February 2016, 1xbet 카지노 FDA granted fast track designation for brexpiprazole for treatment of agitation in patients with Alzheimer's dementia.

"We are incredibly grateful to all 1xbet 카지노 patients with Alzheimer's dementia, 1xbet 카지노ir families and 1xbet 카지노 investigators who participated in 1xbet 카지노 trials and contributed greatly to this research," Dr. Johan Luthman, executive vice president and head of Research & Development at Lundbeck commented. "Researchers will continue to analyze 1xbet 카지노 data set to determine 1xbet 카지노 full potential of brexpiprazole in 1xbet 카지노 treatment of agitation in patients with Alzheimer's dementia. Based on this outcome Otsuka and Lundbeck are planning a regulatory filing to 1xbet 카지노 U. S. Food and Drug Administration later in 2022."