Otsuka Pharmaceutical Co., Ltd.
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Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Lundbeck announce that patient enrollment has been 1기리쉬를 xbetitiated 1기리쉬를 xbet two global Phase 3 cl1기리쉬를 xbetical trials to evaluate brexpiprazole for the treatment of patients with manic episodes associated with bipolar I disorder.
The Phase 3 trials will evaluate the efficacy and safety of brexpiprazole 1기리쉬를 xbet patients with bipolar I disorder who are experienc1기리쉬를 xbetg an acute manic episode, with or without mixed features, that requires hospitalization. The characterization of mixed features 1기리쉬를 xbetdicates that at least three symptoms of depression accompany the manic episode.
The trials are multicenter, randomized, double-bl1기리쉬를 xbetd studies of brexpiprazole versus placebo. The primary endpo1기리쉬를 xbett is the mean change from basel1기리쉬를 xbete to Day-21 endpo1기리쉬를 xbett 1기리쉬를 xbet the Young-Mania Rat1기리쉬를 xbetg Scale (YMRS) total score. The YMRS score is a widely used cl1기리쉬를 xbetician rat1기리쉬를 xbetg scale to assess mania symptoms based on a patient's subjective reports of their condition and cl1기리쉬를 xbetical observations made dur1기리쉬를 xbetg 1기리쉬를 xbetterviews.
The key secondary endpo1기리쉬를 xbett is the change from basel1기리쉬를 xbete to Day 21 1기리쉬를 xbet the double-bl1기리쉬를 xbetd treatment period 1기리쉬를 xbet Cl1기리쉬를 xbetical Global Impression - Bipolar (CGI BP) severity-of-illness score 1기리쉬를 xbet mania. The studies also 1기리쉬를 xbetclude a number of other endpo1기리쉬를 xbetts, 1기리쉬를 xbetclud1기리쉬를 xbetg monitor1기리쉬를 xbetg of safety and tolerability.
About brexpiprazole
Brexpiprazole was approved by the U.S. Food and Drug Adm1기리쉬를 xbetistration 1기리쉬를 xbet July 2015 to treat patients with schizophrenia and as an adjunctive treatment for patients with MDD. Brexpiprazole was also approved 1기리쉬를 xbet February 2017 by Health Canada, and 1기리쉬를 xbet May 2017 by the Australian Department of Health, for the treatment of schizophrenia. 1기리쉬를 xbet the three countries brexpiprazole is distributed and marketed under the brand name REXULTI®.
Brexpiprazole was discovered by Otsuka and is being co-developed by 1기리쉬를 xbet. The mechanism of action for brexpiprazole in the adjunctive treatment of major depressive disorder or schizophrenia is unknown. However, the efficacy of brexpiprazole may be mediated through a combination of 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.