Additional indication for Otsuka's Abilify in Japan

Japanese drugmaker Otsuka Pharmaceutical (TYO: 4768) said last week that it has received new regulatory approvals in Japan for the antipsychotic agent Abilify (aripiprazole). Specifically, the new approvals are for the additional indication "improvement of manic symptoms associated with bipolar disorder" (in addition to the existing indication of schizophrenia), and for the new dosage form "Abilify OD Tablets."

In Phase III clinical trials conducted as international cooperative trials, Abilify was shown to display early improvement of manic symptoms associated with bipolar disorder, the company noted. A manic state can result in elevated energy levels, with impaired judgment and tendency toward anger that interfere with social ability. While proper adherence to medicine is important in the treatment of bipolar disorder, conventional antipsychotic agents have presented the problem of patients discontinuing use due to side effects such as drowsiness. Abilify is less likely to result in these side effects, and is expected to become a first-line drug that can be adhered to without loss of QOL (quality of life).

Abilify is the world's first antipsychotic agent that acts as a dopamine D2 receptor partial agonist. Otsuka commenced marketing Abilify in Japan in June 2006 as a treatment for schizophrenia. In fiscal year 2010, the drug generated sales of around $2.56 billion. Beginning with regulatory approval in the USA in 2004, Abilify has received approval in 57 countries and regions in Europe, Asia, and elsewhere for treatment of manic symptoms associated with bipolar disorder.