July 28, 2017
Otsuka Pharmaceutical Co., Ltd.
Otsuka Submits New Drug Application in Japan for Aripiprazole Sertraline Combination Tablets
Otsuka Pharmaceutical Co., Ltd. today announced the submission of an application for the manufacture and marketing approval in Japan of the aripiprazole sertraline combination tablet, development code ASC-01. The combination tablet is intended as a treatment for major depressive disorder (MDD).
The application is supported by a clinical trial conducted across the Asia and Australasia region, including Japan, with patients with MDD. In the trial, combination therapy arms of four doses of aripiprazole, 3, 6, 9, and 12 mg each with sertraline 100 mg were evaluated against a control arm of sertraline 100 mg monotherapy. The results demonstrated there were no significant differences in observable adverse events between the all treatments, and the combination therapy arms showed improved efficacy compared to the monotherapy arm.
Information in this news release was current as of the original release date.