ABILIFY approved for acute treatment of bipolar I disorder in patients 10 to 17 years old

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, respectively. The mean change from baseline to Week 4 in body weight was 0.6 kilograms (kg) for ABILIFY 10 mg, 0.9 kg for ABILIFY 30 mg and 0.5 kg for placebo.

In this study, ABILIFY demonstrated no clinically important differences on prolactin and the following metabolic parameters: triglyceride, HDL-C, LDL-C and total cholesterol. All treatment groups showed a reduction in mean serum prolactin levels at last visit relative to baseline.

About ABILIFY® (aripiprazole)

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 and pediatric patients (10 to 17 years old). ABILIFY® (aripiprazole) Injection is indicated for the treatment of adults with agitation associated with Bipolar I Disorder, manic or mixed.

Initially approved in November 2002, over 14.9 million prescriptions have been written for ABILIFY in the U.S.(2) through December 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) (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® (aripiprazole) Oral target dose is 15 mg/day to 30 mg/day in Bipolar I Disorder. In pediatric patients (10 to 17 years old) with Bipolar I Disorder, the recommended ABILIFY Oral target dose is 10 mg/day (with a starting dose of 2 mg/day which was titrated to 5 mg/day after 2 days and to the target dose of 10 mg/day after 2 additional days). In adult patients with agitation associated with bipolar mania, 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/day 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.

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY

INDICATIONS:

• ABILIFY is indicated for acute and maintenance treatment of adults with manic or mixed episodes associated with Bipolar I Disorder with or without psychotic features

• ABILIFY is indicated for acute treatment of pediatric patients (10 to 17 years old) with manic or mixed episodes associated with Bipolar I Disorder with or without psychotic features