Bristol-Myers Squibb and Japanese partner, Otsuka Pharmaceutical, were celebrating yesterday after the US Food and Drug Administration gave the green light to the companies’ schizophrenia treatment, Abilify (aripiprazole), for maintaining efficacy in patients with bipolar disorder with a recent manic or mixed episode who had been stabilised and then maintained for at least six weeks.
Approval was based on a 161-patient clinical trial, which showed that patients treated with Abilify for at least six weeks relapsed significantly less that those receiving placebo. In addition, the total number of relapses was significantly fewer in patients treated with Abilify than with placebo (25% versus 43% respectively).
Abilify initially won the nod from the FDA in 2002 for the treatment of schizophrenia [[18/11/02a]]. It is also approved to treat acute manic and mixed episodes associated with bipolar disorder [[04/10/04d]], and has become a key growth driver for the US firm, scoring $191 million dollars worth of sales in the fourth quarter of 2004 – up 139% on the previous year [[28/01/05c]].