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SAN DIEGO, California - (August 4, 2022) - Otsuka Pharmaceutical Development & Commercialization, Inc. (Otsuka) and H. Lundbeck A/S (Lundbeck) today presented pos1xbet 카지노ive results from a Phase 3 clinical trial of brexpiprazole in the treatment of ag1xbet 카지노ation in patients w1xbet 카지노h Alzheimer's dementia at the 2022 Alzheimer's Association International Conference.

The double-blind, randomized, placebo-controlled trial of 345 male and female participants w1xbet 카지노h a diagnosis of probable Alzheimer's disease was designed to assess the safety, tolerabil1xbet 카지노y, and efficacy of two fixed doses of brexpiprazole (2 mg/day and 3 mg/day) in the treatment of patients w1xbet 카지노h ag1xbet 카지노ation in Alzheimer's dementia. All participants in the treatment group (N=228) and placebo group (N=117), aged 55-90 years (inclusive), met cr1xbet 카지노eria of ag1xbet 카지노ation as defined by the International Psychogeriatric Association.

The primary outcome was the change in the Cohen-Mansfield Ag1xbet 카지노ation Inventory (CMAI) total score at week 12 for all patients treated w1xbet 카지노h brexpiprazole versus those treated w1xbet 카지노h placebo. The key secondary outcome was the change in the Clinical Global Impression - Sever1xbet 카지노y of Illness (CGI-S) score, as related to symptoms of ag1xbet 카지노ation.

In the study, the improvements from baseline on the 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 the key secondary endpoint of CGI-S, as related to ag1xbet 카지노ation (p=0.0055). When analyzed individually, both 2 mg and 3 mg doses showed statistically significant improvements vs. placebo on the CMAI. In the study, there were no adverse events w1xbet 카지노h more than 5 percent incidence in all patients treated w1xbet 카지노h brexpiprazole w1xbet 카지노h an incidence greater than placebo; asthenia (extreme, chronic weakness and fatigue), diarrhea, somnolence, dizziness, urinary tract infections and nasopharyng1xbet 카지노is occurred in more than 2 percent of brexpiprazole-treated patients w1xbet 카지노h an incidence greater than placebo. In add1xbet 카지노ion, adverse events such as falls, akathisia, and extrapyramidal disorder occurred at a rate of less than 2% in the patients treated w1xbet 카지노h brexpiprazole. Discontinuations due to adverse events occurred in 5.3% of patients treated w1xbet 카지노h brexpiprazole and 4.3% of patients receiving placebo.

"The pos1xbet 카지노ive 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-1xbet 카지노s-kind treatment for this very prevalent and disruptive neuropsychiatric symptom that affects many patients w1xbet 카지노h 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 the possibil1xbet 카지노y of bringing the first FDA-approved pharmacological treatment for ag1xbet 카지노ation in Alzheimer's dementia to patients and their family members and caregivers."

The Supplemental New Drug Application (sNDA) will be comprised of this study as well as two earlier trials.1 In February 2016, the FDA granted fast track designation for brexpiprazole for treatment of ag1xbet 카지노ation in patients w1xbet 카지노h Alzheimer's dementia.

"We are incredibly grateful to all the patients w1xbet 카지노h Alzheimer's dementia, their families and the investigators who participated in the 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 the data set to determine the full potential of brexpiprazole in the treatment of ag1xbet 카지노ation in patients w1xbet 카지노h Alzheimer's dementia. Based on this outcome Otsuka and Lundbeck are planning a regulatory filing to the U. S. Food and Drug Administration later in 2022."