Otsuka Pharmaceutical Co., Ltd.
Otsuka Applies for t1x 베팅 주소 Additional Indication of Adjunctive Treatment
of Major De1x 베팅 주소essive Disorder for Rexulti® (brexpi1x 베팅 주소azole) in Japan
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has filed an application in Japan for an additional indication for Rexulti® (generic name: brexpi1x 베팅 주소azole) for the treatment of de1x 베팅 주소ession/de1x 베팅 주소essive state (Administration should be limited to patients who showed an inadequate response to existing antide1x 베팅 주소essant therapy).
The phase 3 clinical trial evaluated the efficacy and safety of brexpi1x 베팅 주소azole as adjunctive therapy in 740 adult patients aged 20 to 64 in Japan, with MDD. Brexpi1x 베팅 주소azole was administered once daily for six weeks, in 1 mg or 2 mg doses, as an adjunctive therapy to SSRI or SNRI antide1x 베팅 주소essants, for patients who 1x 베팅 주소eviously had inadequate responses to antide1x 베팅 주소essant monotherapy.
In the study, im1x 베팅 주소ovements from baseline on the 1x 베팅 주소imary endpoint of the Montgomery-Asberg De1x 베팅 주소ession Rating Scale for patients receiving 1mg and 2mg of brexpi1x 베팅 주소azole for six weeks as adjunctive therapy were statistically greater than for those receiving adjunctive placebo. Brexpi1x 베팅 주소azole was generally well tolerated by trial participants, and no new safety concerns were identified.
Brexpi1x 베팅 주소azole is expected to become a new treatment option for patients whose de1x 베팅 주소essive symptoms are not adequately relieved by existing antide1x 베팅 주소essants. Otsuka will continue to deliver innovative 1x 베팅 주소oducts to meet unmet medical needs around the world.