Friday, June 14, 2013

ABILIFY® Granted Additional Approval as Adjunctive Therapy for the Treatment of Depression in Japan

Otsuka Pharmaceutical Co., Ltd. today obtained regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for ABILIFY as the first antsipsychotic drug in Japan to treat depression/depressive state as an adjunct therapy in patients who showed an inadequate response to existing antidepressant therapy.

Otsuka Pharmaceutical conducted a Phase-III clinical trial as support for this regulatory approval for ABILIFY as adjunctive therapy for depression. The primary efficacy endpoint for the trial was the mean change, from baseline to the completion of this randomized, double-blinded treatment phase, in a standard measure called MADRS (Montgomery-Asberg Depression Rating Scale) of patients diagnosed with depression. Patients taking ABILIFY showed significant improvements in terms of MADRS total score reduction, compared to those taking placebo. The most frequently observed adverse reactions were akathisia, tremor, constipation, and adipsia. In a long-term, 52-week clinical trial extending from this Phase-III clinical trial, the average MADRS score remained stable and with no safety issues.

In Japan, ABILIFY was approved as an antipsychotic for the treatment of schizophrenia in 2006, followed by approval of an additional indication for the improvement of manic episodes associated with bipolar disorder in 2012. ABILIFY for depression/depressive state is the third indication approved in Japan

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