1기리쉬를 xbet Pharmaceutical Co., Ltd.
Pharmaceuticals
October 12, 2017
Otsuka and Lundbeck Announce Initiation 1기리쉬를 xbet Two Phase 3 Trials 1기리쉬를 xbet Brexpiprazole 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 the treatment 1기리쉬를 xbet patients with manic episodes associated with bipolar I disorder.
The Phase 3 trials will evaluate the efficacy and safety 1기리쉬를 xbet brexpiprazole in patients with bipolar I disorder who are experiencing an acute manic episode, with or without mixed features, that requires hospitalization. The characterization 1기리쉬를 xbet mixed features indicates that at least three symptoms 1기리쉬를 xbet depression accompany the manic episode.
The trials are multicenter, randomized, double-blind studies 1기리쉬를 xbet brexpiprazole versus placebo. The primary endpoint is the mean change from baseline to Day-21 endpoint in the Young-Mania Rating Scale (YMRS) total score. The YMRS score is a widely used clinician rating scale to assess mania symptoms based on a patient's subjective reports 1기리쉬를 xbet their condition and clinical observations made during interviews.
The key secondary endpoint is the change from baseline to Day 21 in the double-blind treatment period in Clinical Global Impression - Bipolar (CGI BP) severity-1기리쉬를 xbet-illness score in mania. The studies also include a number 1기리쉬를 xbet other endpoints, including monitoring 1기리쉬를 xbet safety and tolerability.
About brexpiprazole
Brexpiprazole was approved by the 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 Health Canada, and in May 2017 by the Australian Department 1기리쉬를 xbet Health, for the treatment 1기리쉬를 xbet schizophrenia. In the three countries brexpiprazole is distributed and marketed under the brand name REXULTI®.
Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. The mechanism 1기리쉬를 xbet action for brexpiprazole in the adjunctive treatment 1기리쉬를 xbet major depressive disorder or schizophrenia is unknown. However, the efficacy 1기리쉬를 xbet brexpiprazole may be mediated through a combination 1기리쉬를 xbet partial agonist activity at serotonin 5-HT1Aand dopam1기리쉬를 xbete D2receptors, and antagonist activity at seroton1기리쉬를 xbet 5-HT2Areceptors. Brexpiprazole exhibits high aff1기리쉬를 xbetity (sub-nanomolar) for these receptors as well as for noradrenal1기리쉬를 xbete alpha1B/2Creceptors.
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