05 Sep 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Japan-based Otsuka Pharmaceutical filed an additional indication for ABILIFY (aripiprazole), as Japan's first antipsychotic agent to be approved for the adjunctive treatment in major depressive disorder.
Depression is a common mental disorder in Japan, experienced by about 1 in 15 people during their lifetime. The prevalence of depression in Japanese people is said to be at a rate of 6.3% during lifetime, and patient numbers have increased 2.4-fold over the last 12 years, reaching 1.4 million in 2008.
Major depressive disorder is commonly called depression, and antidepressant drugs are usually prescribed for its treatment. Patients' symptoms are said to improve by 50-to-60 percent when treated by antidepressant drugs, and the percentage of patients achieving remission by antidepressant drug is said to be 30-to-40 percent. New drug treatment options are desired for the alleviation of depressive disorders, as many patients still find difficulties even when treated with existing antidepressant drugs.
Otsuka conducted a phase III clinical trial aiming to gain approval for ABILIFY as adjunctive therapy in major depressive disorder, in Japan. Based on results of these trials obtained in April 2012, Otsuka Pharmaceutical have filed application in four months, which is considerably a short period of time for filing.
ABILIFY is the world's first antipsychotic drug with a dopamine D2 receptor partial agonist mechanism, which was primarily sold in the United States in 2002, and is now available in over 60 countries and regions worldwide.