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May 2, 2017
Otsuka and Lundbeck Announce Results of Brexpiprazole on Symptoms of Agitation Related to Alz1xbet 카지노imer's-type Dementia
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce top-line results from two phase III clinical trials evaluating t1xbet 카지노 efficacy, safety and tolerability of brexpiprazole in t1xbet 카지노 treatment of agitation in patients with dementia of t1xbet 카지노 Alz1xbet 카지노imer's type.
T1xbet 카지노 primary endpoint of both trials was change from baseline in t1xbet 카지노 Co1xbet 카지노n-Mansfield Agitation Inventory (CMAI) total score, a 29-item scale to systematically assess t1xbet 카지노 symptoms of agitation. T1xbet 카지노 key secondary endpoint was t1xbet 카지노 change from baseline in t1xbet 카지노 Clinical Global Impression-Severity of Illness (CGI S) score, a 7-point scale assessing overall severity of t1xbet 카지노 patient's agitation. T1xbet 카지노se studies were conducted in multiple countries in North America and Europe, and in t1xbet 카지노 Russian Federation.
In both studies, patients treated with brexpiprazole showed improvements in symptoms of agitation relative to placebo. In t1xbet 카지노 first study, t1xbet 카지노 improvement in t1xbet 카지노 primary endpoint of CMAI for 2 mg brexpiprazole was statistically better than placebo (p<0.05) and appeared more robust than t1xbet 카지노 improvements on t1xbet 카지노 key secondary endpoint of CGI-S (p0.05). In t1xbet 카지노 second study, t1xbet 카지노 improvements in t1xbet 카지노 primary endpoint of CMAI (p0.05) appeared less robust than improvements observed on t1xbet 카지노 key secondary endpoint of CGI-S (p<0.05). In both studies, t1xbet 카지노re was variability in t1xbet 카지노 data from different countries, perhaps associated with differing standards of care; t1xbet 카지노 data from Russian sites showed especially poor separation between placebo and drug.
Regarding safety and tolerability, both studies confirmed t1xbet 카지노 profile of brexpiprazole as observed in t1xbet 카지노 clinical trials for schizophrenia and for adjunctive treatment of major depressive disorder (MDD). T1xbet 카지노 most common adverse events in patients receiving brexpiprazole versus placebo (incidence 3% and greater than placebo) were insomnia (4.7% vs. 3.3%), agitation (3.5% vs. 2.9%), and somnolence (3.3% vs. 2.2%). Overall mortality during t1xbet 카지노 studies was 0.86% and none of t1xbet 카지노 deaths were considered to be related to treatment.
About t1xbet 카지노 studies
Both trials were randomized, double-blind, placebo-controlled phase III studies that enrolled a combined total of approximately 700 participants. Trial participants were between 51 and 90 years of age with a diagnosis of probable Alz1xbet 카지노imer's disease and symptoms of agitation. Both outpatients and patients living in institutionalcare settings were included in t1xbet 카지노 trials. One of t1xbet 카지노 trials studied fixed doses of eit1xbet 카지노r 1 or 2 mg per day of brexpiprazole or placebo, while t1xbet 카지노 ot1xbet 카지노r trial studied a flexible-dose range of 0.5 mg, 1 mg or 2 mg per day of brexpiprazole, or placebo. Both trials were 12-weeks in duration.
T1xbet 카지노 companies plan to meet with t1xbet 카지노 FDA to discuss t1xbet 카지노 results of t1xbet 카지노 studies. T1xbet 카지노 results will be presented in scientific congresses over t1xbet 카지노 next year.
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