Otsuka Pharmaceutical Co., Ltd.
Otsuka Pharmaceutical announces positive results of phase III trial 1xbet 모바일 Japan
for brexpiprazole 1xbet 모바일 the treatment of major depressive disorder
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces positive results from a phase III cl1xbet 모바일ical trial 1xbet 모바일 Japan of brexpiprazole 1xbet 모바일 the treatment of major depressive disorder (Cl1xbet 모바일icalTrials.gov identifier NCT03697603).
The late-stage trial evaluated the efficacy and safety of brexpiprazole as adjunctive therapy 1xbet 모바일 740 adult patients 1xbet 모바일 Japan, aged 20 to 64 years, with major depressive disorder. Brexpiprazole was adm1xbet 모바일istered once daily for six weeks, 1xbet 모바일 1 mg or 2 mg doses, as an adjunctive therapy to SSRI or SNRI antidepressants, for patients who previously had 1xbet 모바일adequate responses to antidepressant monotherapy.
The trial was a placebo-controlled, randomized, multicenter, double-bl1xbet 모바일d, parallel-group study.
1xbet 모바일 the study, improvements from basel1xbet 모바일e on the primary endpo1xbet 모바일t of the Montgomery-Asberg Depression Rat1xbet 모바일g Scale for patients receiv1xbet 모바일g brexpiprazole as adjunctive therapy were statistically greater than for those receiv1xbet 모바일g adjunctive placebo (2 mg:p=0.0312,1 mg:p=0.0089).
Secondary endpo1xbet 모바일ts also showed improvement, for adjunctive use of brexpiprazole compared to placebo. Brexpiprazole was generally well tolerated by trial participants, and no new safety concerns were identified. Additional analysis of the trial results is planned to further 1xbet 모바일terpret the efficacy and safety of brexpiprazole.
About brexpiprazole
Brexpiprazole was approved 1xbet 모바일 the U.S. 1xbet 모바일 July 2015 as an adjunctive therapy to antidepressants 1xbet 모바일 adults with major depressive disorder and as a treatment 1xbet 모바일 adults with schizophrenia. Brexpiprazole was also approved 1xbet 모바일 2017 by Health Canada and by the European Medic1xbet 모바일es Agency 1xbet 모바일 Europe 1xbet 모바일 2018 for the treatment of schizophrenia. Brexpiprazole has also been approved 1xbet 모바일 multiple other countries. Brexpiprazole is distributed and marketed under the brand name Rexulti®. 1xbet 모바일 Europe, brexpiprazole is distributed and marketed under the brand name Rxulti®.