Enlarged Indications Of ABILIFY(R) (Aripiprazole) Use
Taro Iwamoto, Ph.D., Chief Executive Officer, President and Chief Operating Officer, Otsuka Pharmaceutical Development and Commercialization, Inc. stated that they are very pleased to receive expanded indications on the use of Abilify (Aripiprazole) in pediatric patients (aged 10-17) and adolescents.
In fact, The FDA first approved ABILIFY antipsychotic medicine for the treatment of manic and mixed episodes associated with Bipolar I Disorder in adults in September 2004, and as schizophrenia medication for adults in November 2002. In 2007-2008 Abilify drug has received the approval for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in pediatric patients, and for the acute treatment of Schizophrenia in adolescents. And now Abilify medication is indicated for maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features and maintenance treatment of Schizophrenia in adolescents. Moreover, ABILIFY antipsychotic medication is given an indication for adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features in pediatric patients.In order to evaluate safety and effectiveness of Aripiprazole tablets in pediatric patients with Bipolar Mania there was conducted a placebo-controlled study involving 197 patients of age 10-17 that lasted four weeks. As for Schizophrenia disease the placebo-controlled study lasted six weeks and contained 202 pediatric patients (aged 13-17).
According to Elliott Sigal, M.D., Ph.D., Executive Vice President, Chief Scientific Officer and President, Research and Development, Bristol-Myers Squibb, expanding the use of Aripiprazole drug supplies the doctors with a new option of Bipolar I Disorder or Schizophrenia treatment in pediatric patients. And it is generally recommended that periodic reassessment should be conducted to determine the need for maintenance treatment.
