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Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals
September 12, 2022

Otsuka Pharmaceutical announces positive results of phase III trial in Japan
for brexpi1xbet 모바일azole in the treatment of major de1xbet 모바일essive disorder

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces positive results from a phase III clinical trial in Japan of brexpi1xbet 모바일azole in the treatment of major de1xbet 모바일essive disorder (ClinicalTrials.gov identifier NCT03697603).

The late-stage trial evaluated the efficacy and safety of brexpi1xbet 모바일azole as adjunctive therapy in 740 adult patients in Japan, aged 20 to 64 years, with major de1xbet 모바일essive disorder. Brexpi1xbet 모바일azole was administered once daily for six weeks, in 1 mg or 2 mg doses, as an adjunctive therapy to SSRI or SNRI antide1xbet 모바일essants, for patients who 1xbet 모바일eviously had inadequate responses to antide1xbet 모바일essant monotherapy.

T1xbet 모바일 trial was a placebo-controlled, randomized, multicenter, double-blind, parallel-group study.

In the study, im1xbet 모바일ovements from baseline on the 1xbet 모바일imary endpoint of the Montgomery-Asberg De1xbet 모바일ession Rating Scale for patients receiving brexpi1xbet 모바일azole as adjunctive therapy were statistically greater than for those receiving adjunctive placebo (2 mg:p=0.0312,1 mg:p=0.0089).

Secondary endpoints also showed im1xbet 모바일ovement, for adjunctive use of brexpi1xbet 모바일azole compared to placebo. Brexpi1xbet 모바일azole was generally well tolerated by trial participants, and no new safety concerns were identified. Additional analysis of the trial results is planned to further inter1xbet 모바일et the efficacy and safety of brexpi1xbet 모바일azole.

About brexpi1xbet 모바일azole

Brexpi1xbet 모바일azole was ap1xbet 모바일oved in the U.S. in July 2015 as an adjunctive therapy to antide1xbet 모바일essants in adults with major de1xbet 모바일essive disorder and as a treatment in adults with schizophrenia. Brexpi1xbet 모바일azole was also ap1xbet 모바일oved in 2017 by Health Canada and by the European Medicines Agency in Europe in 2018 for the treatment of schizophrenia. Brexpi1xbet 모바일azole has also been ap1xbet 모바일oved in multiple other countries. Brexpi1xbet 모바일azole is distributed and marketed under the brand name Rexulti®. In Europe, brexpi1xbet 모바일azole is distributed and marketed under the brand name Rxulti®.