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US FDA approves ABILIFY for adolescent patients with schizophrenia

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

The findings are from a six-week, double-blind, randomized, placebo-controlled, multi-center study that evaluated the efficacy and safety of ABILIFY in pediatric patients, 13-17 years old, with a primary diagnosis of schizophrenia. (1) The study, sponsored by Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, N.J.), was conducted at 101 centers in 13 countries and enrolled 302 ethnically diverse pediatric patients. All patients were experiencing an acute episode of schizophrenia and required hospitalization at the time of enrollment. (1) After a minimum three-day wash-out period without any antipsychotic treatment, pediatric patients were randomly assigned to receive one of two fixed doses of ABILIFY [10 mg/day (n=100) or 30 mg/day (n=102)] or placebo (n=100). (1) ABILIFY was started at 2 mg/day and titrated to the target dose. (1)

The primary efficacy endpoint was the mean change from baseline to endpoint (Week 6) in a standard measure called the PANSS Total Score, (1) which can range from 30 (no symptoms) to 210 points (most severe symptoms). (2) Safety evaluations included incidence of adverse events, discontinuation rate due to adverse events and laboratory measures. (1)

Approximately 85 percent of patients completed the six-week study (84 percent of ABILIFY 10 mg, 82 percent of ABILIFY 30 mg and 90 percent of placebo-treated patients). (1) Both doses of ABILIFY demonstrated significant improvement when compared to placebo in mean change from baseline to endpoint (Week 6) in PANSS Total Score. (1)

In this study of pediatric patients with schizophrenia, common adverse events (greater than or equal to 5 percent and at least twice the rate of placebo) associated with ABILIFY were extrapyramidal disorder, somnolence and tremor. These common adverse reactions appeared to have a possible dose response relationship: extrapyramidal disorder (ABILIFY 10 mg: 13 percent; ABILIFY 30 mg: 21.6 percent; placebo: 5 percent), somnolence (ABILIFY 10 mg: 11 percent; ABILIFY 30 mg: 21.6 percent; placebo: 6 percent) and tremor (ABILIFY 10 mg: 2 percent; ABILIFY 30 mg: 11.8 percent; placebo: 2 percent). The discontinuation rate due to an adverse event was 5 percent for ABILIFY and 2 percent for placebo.

In this six-week study, weight gain greater than or equal to 7 percent increase from baseline was seen in 5 percent of pediatric patients treated with ABILIFY and 1 percent of placebo-treated patients. The mean change from baseline in weight was 0.13 kilograms (kg) for ABILIFY and -0.83 kg for placebo.


The first and only available dopamine partial agonist, ABILIFY is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults. ABILIFY is also indicated for the treatment of schizophrenia in adults and adolescents (13-17 years old). ABILIFY Injection is indicated for the treatment of adults with agitation associated with schizophrenia or Bipolar I Disorder, manic or mixed.

Initially approved in November 2002, over 12.5 million prescriptions have been written for ABILIFY in the U.S. (3) through June 2007.

ABILIFY is available by prescription only. ABILIFY tablets should be taken once daily with or without food and are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths. ABILIFY DISCMELT (TM) Orally Disintegrating Tablets are available in 10 mg and 15 mg strengths. In addition, ABILIFY is available in a 1 mg/mL nonrefrigerated oral solution and as a single-dose ready-to-use solution for intramuscular injection 7.5 mg/mL. In adult patients, the recommended ABILIFY oral target dose is 15 mg to 30 mg/day in Bipolar I Disorder and 10 mg to 15 mg/day in schizophrenia. In adolescent patients with schizophrenia, the recommended ABILIFY oral target dose is 10 mg/day (with a starting dose of 2 mg/day which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days). The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. In adult patients with agitation associated with bipolar mania or schizophrenia, the ABILIFY Injection initial dose is 9.75 mg/1.3 mL. If ongoing ABILIFY therapy is clinically indicated, oral ABILIFY in a range of 10 mg to 30 mg/day should replace ABILIFY Injection as soon as possible. The safety of doses of ABILIFY oral or ABILIFY Injection above 30 mg/day has not been evaluated in clinical trials.


Contact: Debra Kaufmann
Otsuka America Pharmaceutical, Inc.

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