Otsuka Pharmaceutical Co., Ltd and Bristol-Myers Squibb Company have announced that a new drug for treatment of bipolar disorder in children and adolescents is now available. ABILIFY (aripiprazole) has been approved by the FDA for patients 10 to 17 years old for the treatment of acute manic and mixed episodes of Bipolar I Disorder, with or without psychotic features. The approval is based on the results of a 4-week double-blind, randomized, multi-center, placebo-controlled study, which showed efficacy, as measured by the mean change from baseline to week 4 on the Young-Mania Rating Scale (Y-MRS) Total Score.

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.

“Pediatric bipolar illness is a serious condition,” said Christoph Correll, M.D., Medical Director, Recognition and Prevention Program, The Zucker Hillside Hospital and Assistant Professor of Psychiatry and Behavioral Sciences, Albert Einstein College of Medicine, Glen Oaks, New York. “The availability of an additional treatment option that can help guide decisions in managing Bipolar I Disorder in children and adolescents is welcome news.”

ABILIFY has been approved for the acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in adults since September 2004 and March 2005, respectively. ABILIFY is administered as a prescription only drug in the most common form of tablets taken once a day.

Source: Bristol-Myers Squibb

• Although the drug has already been approved for adults, do you think that a 4 week trial is long enough to determine safety and efficacy in the 10-17 years old age group?