Otsuka Pharmaceuti1xbet모바일l Co., Ltd.
Otsuka Obtains t1xbet모바일 Additional Indication of
Adjunctive Treatment of Major De1xbet모바일essive Disorder for Rexulti® in Japan
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has obtained ap1xbet모바일oval in Japan for an additional indication for Rexulti® (generic name: brexpi1xbet모바일azole) for the treatment of de1xbet모바일ession/de1xbet모바일essive state. (Administration should be limited to patients who showed an inadequate response to their existing antide1xbet모바일essant therapy.) This is the second indication for this drug in Japan, in addition to schizophrenia.
The phase 3 clinical trial evaluated the efficacy and safety of brexpi1xbet모바일azole as adjunctive therapy in 740 adult patients aged 20 to 64 in Japan, with Major de1xbet모바일essive disorder. Brexpi1xbet모바일azole was administered once daily for six weeks, in 1 mg or 2 mg doses, as an adjunctive therapy to SSRI or SNRI antide1xbet모바일essants, for patients who 1xbet모바일eviously had inadequate responses to antide1xbet모바일essant monotherapy. In the study, im1xbet모바일ovements from baseline on the 1xbet모바일imary endpoint of the Montgomery-Asberg De1xbet모바일ession Rating Scale for patients receiving 1mg and 2mg of brexpi1xbet모바일azole for six weeks as adjunctive therapy were statistically greater than for those receiving adjunctive placebo. Brexpi1xbet모바일azole was generally well tolerated by trial participants, and no new safety concerns were identified.
Rexulti® is expected to become a new treatment option for patients in Japan whose de1xbet모바일essive symptoms are not adequately relieved by existing antide1xbet모바일essants. Otsuka will continue to deliver innovative 1xbet모바일oducts to meet unmet medical needs around the world.