TOKYO, JAPAN and PRINCETON, NJ, Nov. 6, 2007 -- Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application for the atypical antipsychotic ABILIFY(R) (aripiprazole) for the treatment of schizophrenia in adolescents aged 13-17 years. In adolescents, ABILIFY treats positive and negative symptoms of schizophrenia. The FDA first approved ABILIFY for the treatment of schizophrenia in adults on November 15, 2002.
"Until now, FDA-approved treatment options for adolescent patients with schizophrenia were limited," said Robert Findling, M.D., Director of Child and Adolescent Psychiatry, University Hospitals Case Medical Center, Cleveland, Ohio. "The approval of this new indication for ABILIFY provides an additional effective treatment option for these patients."
This approval is based on results from a six-week, randomized, double-blind, placebo-controlled study that demonstrated significant improvement with ABILIFY compared to placebo on the primary efficacy endpoint, Positive and Negative Syndrome Scale (PANSS) Total Score. (1)
"We are extremely pleased that ABILIFY, the first available dopamine partial agonist, is approved for the treatment of pediatric patients (13 to 17 years of age) suffering from schizophrenia," said Tatsuo Higuchi, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "ABILIFY offers an effective new option to help treat this serious mental illness."
"Schizophrenia is one of the most complex of all mental health disorders," said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb. "We remain committed to providing innovative therapies, such as ABILIFY, to help patients, including adolescents, living with schizophrenia."
Clinical Trial Design and Findings
|Contact: Debra Kaufmann|
Otsuka America Pharmaceutical, Inc.