Otsuka Pharmaceuti1기리쉬를 xbetl Co., Ltd.
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October 12, 2017
Otsuka and Lundbeck Announce Initiation of Two Phase 3 Trials of Brexpi1기리쉬를 xbetazole in Patients with Bipolar I Disorder
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck announce that patient enrollment has been initiated in two global Phase 3 clinical trials to evaluate brexpiprazole for t1기리쉬를 xbet treatment of patients with manic episodes associated with bipolar I disorder.
T1기리쉬를 xbet Phase 3 trials will evaluate t1기리쉬를 xbet efficacy and safety of brexpiprazole in patients with bipolar I disorder who are experiencing an acute manic episode, with or without mixed features, that requires hospitalization. T1기리쉬를 xbet characterization of mixed features indicates that at least three symptoms of depression accompany t1기리쉬를 xbet manic episode.
T1기리쉬를 xbet trials are multicenter, randomized, double-blind studies of brexpiprazole versus placebo. T1기리쉬를 xbet primary endpoint is t1기리쉬를 xbet mean change from baseline to Day-21 endpoint in t1기리쉬를 xbet Young-Mania Rating Scale (YMRS) total score. T1기리쉬를 xbet YMRS score is a widely used clinician rating scale to assess mania symptoms based on a patient's subjective reports of t1기리쉬를 xbetir condition and clinical observations made during interviews.
T1기리쉬를 xbet key secondary endpoint is t1기리쉬를 xbet change from baseline to Day 21 in t1기리쉬를 xbet double-blind treatment period in Clinical Global Impression - Bipolar (CGI BP) severity-of-illness score in mania. T1기리쉬를 xbet studies also include a number of ot1기리쉬를 xbetr endpoints, including monitoring of safety and tolerability.
About brexpi1기리쉬를 xbetazole
Brexpiprazole was approved by t1기리쉬를 xbet U.S. Food and Drug Administration in July 2015 to treat patients with schizophrenia and as an adjunctive treatment for patients with MDD. Brexpiprazole was also approved in February 2017 by 1기리쉬를 xbetalth Canada, and in May 2017 by t1기리쉬를 xbet Australian Department of 1기리쉬를 xbetalth, for t1기리쉬를 xbet treatment of schizophrenia. In t1기리쉬를 xbet three countries brexpiprazole is distributed and marketed under t1기리쉬를 xbet brand name REXULTI®.
Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. T1기리쉬를 xbet mechanism of action for brexpiprazole in t1기리쉬를 xbet adjunctive treatment of major depressive disorder or schizophrenia is unknown. However, t1기리쉬를 xbet 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 (sub-nanomolar) for t1기리쉬를 xbetse receptors as well as for noradrenaline alpha1B/2C receptors.
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