Sunday, September 2, 2012

Otsuka Pharma files Abilify for approval as an adjunctive treatment in Major Depressive Disorder in Japan

Otsuka Pharmaceutical, has filed for additional indication as adjunctive therapy for major depressive disorder. The filing is for use as adjunct therapy in which ABILIFY is added to and used alongside existing treatment when sufficient effect is not obtained with antidepressant drugs(SSRI, SNRI). The filing is based on results from a Phase 3 trial, which showed results in April this year. ABILIFY is already approved for use as an adjunct treatment in MDD patients in the US. Major depressive disorder is commonly called depression, and antidepressant drugs are usually prescribed for its treatment. Patients' symptoms are said to improve by 50-60% when treated by antidepressant drugs, and the percentage of patients achieving remission by antidepressant drug is said to be 30-40%. 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.