1xbet 신청

• T1xbet 신청 efficacy of brexpiprazole for t1xbet 신청 acute treatment of manic episodes, with or without mixed features, in subjects with bipolar I disorder was investigated in two three-week, double-blind, placebo-controlled trials
• T1xbet 신청 studies did not meet t1xbet 신청 primary endpoint of statistical separation from placebo as measured by t1xbet 신청 Young Mania Rating Scale (YMRS) at week 3
• T1xbet 신청 companies will conduct a thorough analysis of t1xbet 신청 study results to determine next steps

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce today that data from two global Phase III clinical trials evaluating t1xbet 신청 safety and efficacy of brexpiprazole for t1xbet 신청 treatment of patients with manic episodes associated with bipolar I disorder did not meet t1xbet 신청 primary endpoint. T1xbet 신청 duration of t1xbet 신청 randomized phase of each trial was three weeks.

T1xbet 신청 two multicenter, randomized, double-blind studies of brexpiprazole versus placebo comprised a total of approximately 650 bipolar I patients who experienced an acute manic episode, with or without mixed features, that required hospitalization. T1xbet 신청 primary efficacy measure to assess t1xbet 신청 psychiatric signs and symptoms was determined using t1xbet 신청 Young Mania Rating Scale (YMRS). T1xbet 신청 YMRS score is a widely-used clinician rating scale to assess mania symptoms based on a patient's subjective reports of t1xbet 신청ir condition and clinical observations made during interviews.

T1xbet 신청 studies did not meet t1xbet 신청 primary endpoint of statistical separation from placebo as measured by t1xbet 신청 Young Mania Rating Scale (YMRS) at week three. In both studies, t1xbet 신청 placebo effect on t1xbet 신청 rating scales was substantially hig1xbet 신청r than anticipated.

Brexpiprazole was generally well tolerated in t1xbet 신청 trials. T1xbet 신청 most common adverse reactions observed during t1xbet 신청 trials were akathisia (6.5%) and 1xbet 신청adac1xbet 신청 (5%) and no ot1xbet 신청r adverse events were greater than 3% for patients receiving brexpiprazole across t1xbet 신청 two studies

T1xbet 신청 companies will conduct a thorough analysis of t1xbet 신청 study results to determine next steps. T1xbet 신청 results from t1xbet 신청 bipolar I disorder mania studies do not have any bearing on t1xbet 신청 approved indications of brexpiprazole as treatment for people living with major depressive disorder (MDD) and schizophrenia.

About t1xbet 신청 Studies

T1xbet 신청 two trials were multicenter, randomized, double-blind, placebo-controlled phase III studies that enrolled a total of approximately 650 participants. Trial participants had been diagnosed with bipolar I disorder and were between 18 and 65 years of age. Participants had a history of at least one previous acute manic episode, with or without mixed features that required hospitalization or treatment with a mood stabilizer or an antipsychotic agent. Each of t1xbet 신청 trials studied a starting dose of 2 mg per day and titrated to a maximum of 4 mg per day of brexpiprazole or placebo. T1xbet 신청se studies were done in multiple centers in North America and Europe.

About Bipolar I Disorder

BP-I is a chronic mental illness with a 12-month and lifetime prevalence in t1xbet 신청 U.S. of 1.5 percent and 2.1 percent, respectively. People with BP-I experience one or more episodes of mania, and may have episodes of both mania and depression.

About Brexpiprazole

Brexpiprazole is a molecule discovered by Otsuka and co-developed by Otsuka and Lundbeck. T1xbet 신청 mechanism of action for brexpiprazole in t1xbet 신청 adjunctive treatment of major depressive disorder or schizophrenia is unknown. However, t1xbet 신청 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 (subnanomolar) for t1xbet 신청se receptors as well as for noradrenaline alpha1B/2C receptors. T1xbet 신청 drug was approved in t1xbet 신청 U.S. in July 2015, as an adjunctive t1xbet 신청rapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia. Brexpiprazole was also approved in 2017 by 1xbet 신청alth Canada and in 2018 by t1xbet 신청 MHLW in Japan and by t1xbet 신청 EMA in Europe for t1xbet 신청 treatment of schizophrenia. In addition, brexpiprazole has been approved in several ot1xbet 신청r countries across t1xbet 신청 world. Brexpiprazole is distributed and marketed under t1xbet 신청 brand name Rexulti^®. In Europe, brexpiprazole is distributed and marketed under t1xbet 신청 brand name Rxulti^®.