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ABILIFY approved for acute treatment of bipolar I disorder in patients 10 to 17 years old
Date:2/29/2008

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

Clinical Trial Design and Findings

These findings are from a four-week, multicenter, randomized, double-blind, placebo-controlled study, which evaluated the efficacy and safety of ABILIFY in 296 pediatric patients (10 to 17 years old) with a DSM-IV diagnosis of Bipolar I Disorder, manic or mixed episodes, with or without psychotic features. Diagnosis was made by a trained child and adolescent psychiatrist and confirmed by a separate diagnostic interview. This study was conducted on an outpatient basis with the possibility of inpatient hospitalization, as needed. This clinical trial was sponsored by Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ) with enrollment at 54 U.S. centers.

After a screening period of up to four weeks, pediatric patients (10 to 17 years old) who scored greater than or equal to 20 on the Y-MRS* were randomly assigned to receive one of two fixed doses of ABILIFY [10 mg/day (n=98) or 30 mg/day (n=99)] or placebo (n=99). ABILIFY was initiated at a starting dose of 2 mg/day and titrated to the target dose of 10 mg/day or 30 mg/day.

The primary efficacy endpoint was the mean change in the Y-MRS Total Score from baseline to Week 4. Safety evaluations included incidence of adverse reactions, discontinuation due to adverse reactions, laboratory measures and body weight.

For the primary endpoint, both doses of ABILIFY demonstrated statistically significant improvement in symptoms when compared to placebo (p-value less t
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Contact: Debra Kaufmann
debra.kaufmann@otsuka.com
240-683-3568
Otsuka America Pharmaceutical, Inc.
Source:Eurekalert

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