B-MS and Otsuka submit aripiprazole

Bristol-Myers Squibb and Japan's Otsuka Pharmaceuticals have filed aNew Drug Application with the US Food and Drug Administration for aripiprazole for the treatment of schizophrenia. The companies say that, if approved, the drug will become the first member of the next-generation of atypical antipsychotics.

Based on data from a global clinical development program involving more than 3,000 patents with schizophrenia, the firms expect further marketing applications to be made worldwide, including with the European Medicines Evaluation Agency, later this year.

"While currently-available antipsychotic drugs help many patients, there is a substantial number of patients who exhibit either partial or inadequate response to therapy or who discontinue their treatment prematurely," according to Jeffrey Lieberman, vice chairman of psychiatry at the University of North Carolina, USA, quoted in a joint B-MS/Otsuka press statement.