U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Yea... (rom baseline to Week 4. Safety evaluatio...)

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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

Date:2/29/2008

rom 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 than 0.0001) as measured by the mean change from baseline to endpoint (Week 4) on the Y-MRS Total Score. The efficacy of ABILIFY for the maintenance treatment of Bipolar I Disorder in the pediatric population has not been evaluated.

Approximately 80% of patients completed the four-week study (ABILIFY 10 mg: 86%; ABILIFY 30 mg: 78%; placebo: 77%). There was a low rate of discontinuation due to adverse reactions at Week 4 (ABILIFY: 7%; placebo: 2%).

During the study, the most commonly observed adverse reactions (greater than or equal to 5% in combined ABILIFY groups and at least twice the rate of placebo) associated with ABILIFY were: somnolence (ABILIFY: 23%; placebo: 3%), extrapyramidal disorder (ABILIFY: 20%; placebo: 3%), fatigue (ABILIFY: 11%; placebo: 4%), nausea (ABILIFY: 11%; placebo: 4%), akathisia (ABILIFY: 10%; placebo: 2%), blurred vision (ABILIFY: 8%; placebo: 0%), salivary hypersecretion (ABILIFY: 6%; placebo: 0%) and dizziness (ABILIFY: 5%; placebo: 1%). Four common adverse reactions had a possible dose-response relationship at Week 4: extrapyramidal disorder (ABILIFY 10 mg: 12.2%; ABILIFY 30 mg: 27.3%; placebo: 3.1%), somnolence (ABILIFY 10 mg: 19.4%; ABILIFY 30 mg: 26.3%; placebo: 3.1%), akathisia (ABILIFY 10 mg: 8.2%; ABILIFY 30 mg: 11.1%; placebo: 2.1%) and salivary hypersecretion (ABILIFY 10 mg: 3.1%; ABILIFY 30 mg: 8.1%; placebo: 0%). Children and adolescents might be more sensitive than adults in developing antipsychotic-related adverse events.(1)

In the study, weight gain greater than or equal to 7% change from baseline was seen in 3.2%, 9.4% and 3.3% for the ABILIFY 10 mg, ABILIFY 30 mg and placebo groups, res
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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Yea...(rom baseline to Week 4. Safety evaluatio...),Health