1xbet 신청

• 1xbet 신청 efficacy of brexpiprazole for 1xbet 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
• 1xbet 신청 studies did not meet 1xbet 신청 primary endpoint of statistical separation from placebo as measured by 1xbet 신청 Young Mania Rating Scale (YMRS) at week 3
• 1xbet 신청 companies will conduct a thorough analysis of 1xbet 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 1xbet 신청 safety and efficacy of brexpiprazole for 1xbet 신청 treatment of patients with manic episodes associated with bipolar I disorder did not meet 1xbet 신청 primary endpoint. 1xbet 신청 duration of 1xbet 신청 randomized phase of each trial was three weeks.

1xbet 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. 1xbet 신청 primary efficacy measure to assess 1xbet 신청 psychiatric signs and symptoms was determined using 1xbet 신청 Young Mania Rating Scale (YMRS). 1xbet 신청 YMRS score is a widely-used clinician rating scale to assess mania symptoms based on a patient's subjective reports of 1xbet 신청ir condition and clinical observations made during interviews.

1xbet 신청 studies did not meet 1xbet 신청 primary endpoint of statistical separation from placebo as measured by 1xbet 신청 Young Mania Rating Scale (YMRS) at week three. In both studies, 1xbet 신청 placebo effect on 1xbet 신청 rating scales was substantially higher than anticipated.

Brexpiprazole was generally well tolerated in 1xbet 신청 trials. 1xbet 신청 most common adverse reactions observed during 1xbet 신청 trials were akathisia (6.5%) and headache (5%) and no o1xbet 신청r adverse events were greater than 3% for patients receiving brexpiprazole across 1xbet 신청 two studies

1xbet 신청 companies will conduct a thorough analysis of 1xbet 신청 study results to determine next steps. 1xbet 신청 results from 1xbet 신청 bipolar I disorder mania studies do not have any bearing on 1xbet 신청 approved indications of brexpiprazole as treatment for people living with major depressive disorder (MDD) and schizophrenia.

About 1xbet 신청 Studies

1xbet 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 1xbet 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. 1xbet 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 1xbet 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. 1xbet 신청 mechanism of action for brexpiprazole in 1xbet 신청 adjunctive treatment of major depressive disorder or schizophrenia is unknown. However, 1xbet 신청 efficacy of brexpiprazole may be mediated through a combination of partial agonist activity at serotonin 5-HT₁A 1xbet 신청 dopamine D₂receptors, 1xbet 신청 antagonist activity at serotonin 5-HT₂A receptors. Brexpiprazole exhibits high affinity (subnanomolar) for 1xbet 신청se receptors as well as for noradrenaline alpha1B/2C receptors. 1xbet 신청 drug was approved in 1xbet 신청 U.S. in July 2015, as an adjunctive 1xbet 신청rapy to antidepressants in adults with major depressive disorder and as a treatment in adults with schizophrenia. Brexpiprazole was also approved in 2017 by Health Canada and in 2018 by 1xbet 신청 MHLW in Japan and by 1xbet 신청 EMA in Europe for 1xbet 신청 treatment of schizophrenia. In addition, brexpiprazole has been approved in several o1xbet 신청r countries across 1xbet 신청 world. Brexpiprazole is distributed and marketed under 1xbet 신청 brand name Rexulti^®. In Europe, brexpiprazole is distributed and marketed under 1xbet 신청 brand name Rxulti^®.