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"Pediatric bipolar illness is a serious condition," said ChristophCorrell, M.D., Medical Director, Recognition and Prevention Program, TheZucker Hillside Hospital and Assistant Professor of Psychiatry and BehavioralSciences, Albert Einstein College of Medicine, Glen Oaks, New York. "Theavailability of an additional treatment option that can help guide decisionsin managing Bipolar I Disorder in children and adolescents is welcome news."
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The approval is based on results from a four-week, multicenter, randomized,double-blind, placebo-controlled study in pediatric patients (10 to 17 yearsold) with Bipolar I Disorder that demonstrated efficacy with ABILIFY comparedto placebo on the primary efficacy endpoint, mean change from baseline to Week4 on the Young-Mania Rating Scale (Y-MRS) Total Score.
"We are pleased that the FDA has approved ABILIFY to treat pediatricpatients aged 10 to 17 years suffering from Bipolar I Disorder," said TaroIwamoto, Ph.D., Chief Executive Officer, President and Chief OperatingOfficer, Otsuka Pharmaceutical Development and Commercialization, Inc. "Theapproval of this new indication for ABILIFY provides clinicians with expandedtreatment options that can help address the therapeutic needs of thispopulation."
"We are committed to developing innovative new medicines to their fullestpotential," said Elliott Sigal, M.D., Ph.D., Executive Vice President, ChiefScientific Officer and President, Research and Development, Bristol-MyersSquibb. "Expanding the clinical use of an important therapy such as ABILIFYgives pediatric patients with Bipolar I Disorder and their caregivers a newtreatment 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 ABILIFYin 296 pediatric patients (10 to 17 years old) with a DSM-IV diagnosis ofBipolar I Disorder, manic or mixed episodes, with or without psychoticfeatures. Diagnosis was made by a trained child and adolescent psychiatristand confirmed by a separate diagnostic interview. This study was conducted onan outpatient basis with the possibility of inpatient hospitalization, asneeded. 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 to17 years old) who scored greater than or equal to 20 on the Y-MRS* wererandomly 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 astarting dose of 2 mg/day and titrated to the target dose of 10 mg/day or30 mg/day.
The primary efficacy endpoint was the mean change in the Y-MRS Total Scorefrom baseline to Week 4. Safety evaluations included incidence of adversereactions, discontinuation due to adverse reactions, laboratory measures andbody weight.
For the primary endpoint, both doses of ABILIFY demonstrated statisticallysignificant improvement in symptoms when compared to placebo (p-value lessthan 0.0001
