FDA To Review ABILIFY Supplemental New Drug Application
Otsuka Pharmaceutical Co., Ltd. and Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and granted a Priority Review to the supplemental New Drug Application (sNDA) of the atypical antipsychotic ABILIFY (aripiprazole) for the treatment of pediatric patients (10 to 17 years old) diagnosed with Bipolar I Disorder, manic or mixed episode with or without psychotic features.
Priority Review status for an application or supplement for a drug product is assigned if a product, if approved, could represent an improvement compared to marketed products, including non-drug products/therapies in the treatment, diagnosis or prevention of a disease. The FDA goal for reviewing a drug with Priority Review is six months.
This sNDA is based on data from a multicenter, randomized double-blind, placebo-controlled study of two fixed oral doses of ABILIFY (10 mg/day or 30 mg/day). The efficacy and safety of ABILIFY were assessed in 296 ethnically diverse pediatric patients (ages 10 to 17) with Bipolar I Disorder over a 30- week treatment timeframe, which consisted of a four-week double-blind acute phase, followed by a 26-week double-blind continuation phase. This trial was sponsored by Otsuka Pharmaceutical Co., Ltd. and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, NJ) and was conducted at 54 centers in the U.S.
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. ABILIFY is also indicated for the treatment of schizophrenia in adults and adolescents (13 to 17 years old). ABILIFY (aripiprazole) Injection is indicated for the treatment of adults with agitation associated with schizophrenia or Bipolar I Disorder, manic or mixed.
Initially approved in November 2002, over 12.5 million prescriptions have been written for ABILIFY in the U.S.(*1) through June 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 (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 Oral target dose is 15 mg/day to 30 mg/day in Bipolar I Disorder and 10 mg/day to 15 mg/day in schizophrenia.
In adolescent patients with schizophrenia, 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