FDAnews
www.fdanews.com/articles/87117-bms-otsuka-report-aripiprazole-study-findings

BMS, OTSUKA REPORT ARIPIPRAZOLE STUDY FINDINGS

May 26, 2006

New York-based Bristol-Myers Squibb (BMS) and Otsuka Pharmaceutical, headquartered in Japan, have reported that in a recent study, an atypical antipsychotic medicine, aripiprazole, demonstrated significantly greater improvement versus standard-of-care treatment.

The study, called STAR (Schizophrenia Trial of ARipiprazole), was a six-month, randomized, open-label, multicenter trial of 555 adults living with schizophrenia conducted in Europe. In the trial, those with schizophrenia whose clinical symptoms were not optimally controlled or who experienced tolerability problems with their current medication were randomized to either aripiprazole or one of three standard-of-care therapies -- olanzapine, quetiapine or risperidone . The choice of standard-of-care was based on physician discretion; the results from subjects on a standard-of-care therapy were analyzed and reported as one group.

At Week 26 of the study, the mean efficacy score was significantly lower for adults taking aripiprazole compared with standard-of-care treatment. A greater proportion of aripiprazole-treated adults were rated by the investigator as "very much improved" or "much improved."