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Aipiprazole Receives Expanded Indications in Bipolar I Disorder and Schizophrenia

TOKYO & PRINCETON, N.J.--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company (NYSE: BMY - News) announced that ABILIFY® (aripiprazole) received expanded indications in Bipolar I Disorder and Schizophrenia. ABILIFY is now indicated for maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in pediatric patients (aged 10-17) and maintenance treatment of Schizophrenia in adolescents (aged 13-17). In addition, ABILIFY is also granted an indication for adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in pediatric patients (aged 10-17).

ABILIFY was recently approved for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in pediatric patients (aged 10-17), in February 2008, and for the acute treatment of Schizophrenia in adolescents (aged 13-17) in October 2007. The FDA first approved ABILIFY for the treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults in September 2004, and for the treatment of Schizophrenia in adults in November 2002.

The safety and effectiveness of ABILIFY in pediatric patients with Bipolar Mania were established in a four-week, placebo-controlled clinical trial in 197 pediatric patients (aged 10-17). The safety and effectiveness of ABILIFY in adolescents with Schizophrenia were established in a six-week, placebo-controlled clinical trial in 202 pediatric patients (aged 13-17). Although maintenance efficacy in these patient populations has not been systematically evaluated, maintenance efficacy can be extrapolated from adult data along with comparisons of ABILIFY pharmacokinetic parameters in adults and pediatric patients.

There is no body of evidence available to answer the question of how long the adolescent patient treated with ABILIFY should be maintained. It is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Periodic reassessment should be conducted to determine the need for maintenance treatment.

The efficacy of adjunctive ABILIFY with concomitant lithium or valproate in the treatment of manic or mixed episodes in pediatric patients has not been systematically evaluated. However, such efficacy and lack of pharmacokinetic interaction between ABILIFY and lithium or valproate can be extrapolated from adult data along with comparisons of ABILIFY pharmacokinetic parameters in adult and pediatric patients.

“We are extremely pleased to receive expanded indications on the use of ABILIFY in these patient populations,” said Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc.

“Expanding the clinical uses of an important therapy such as ABILIFY gives caregivers and pediatric patients with Bipolar I Disorder or Schizophrenia a new treatment option in their fight against serious disease,” said Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb.

About ABILIFY
The first and only available dopamine partial agonist, ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the acute treatment of Major Depression Disorder in adults. ABILIFY is also indicated for acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults and pediatric patients (aged 10-17). Additionally, ABILIFY is indicated as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults and in pediatric patients (aged 10-17). ABILIFY is also indicated for acute and maintenance treatment of Schizophrenia in adults and in adolescents (aged 13-17).

ABILIFY® (aripiprazole) Injection is indicated for the acute treatment of agitation associated with Schizophrenia or Bipolar Disorder, manic or mixed in adults.

Initially approved in November 2002, over 20 million prescriptions have been written for ABILIFY in the U.S.(1) through March 2008.

ABILIFY is available by prescription only. ABILIFY should be taken once daily with or without food and is available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablet strengths. ABILIFY DISCMELT® (aripiprazole) 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 target and starting dose is 15 mg/day in Bipolar I Disorder and 10 mg to 15 mg/day in Schizophrenia. In pediatric patients (aged 10-17) with Bipolar I Disorder, the recommended ABILIFY target dose is 10 mg/day (with a starting dose of 2 mg/day which was titrated to 5 mg/day after two days and to the target dose of 10 mg/day after two additional days). In adolescents with Schizophrenia, the recommended ABILIFY target dose is 10 mg/day (with a starting dose of 2 mg/day which was titrated to 5 mg after two days and to the target dose of 10 mg after two 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 oral ABILIFY or ABILIFY Injection above 30 mg/day has not been evaluated in clinical trials.

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY
INDICATIONS:
* ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the acute treatment of Major Depression Disorder in adults * ABILIFY is indicated for acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults and pediatric patients 10 to 17 years of age * ABILIFY is indicated as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults and pediatrics 10 to 17 years of age * ABILIFY is indicated for acute and maintenance treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age * ABILIFY Injection is indicated for the acute treatment of agitation associated with Schizophrenia or Bipolar Disorder, manic or mixed in adults

Source: Otsuka Pharmaceutical Co. and Bristol-Myers Squibb Company

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