Drug to treat children with bipolar disorder gets priority review

Nov 15 2007

An anti-psychotic drug already approved in the U.S. to treat adults and adolescents with schizophrenia may soon be available for youngsters age 10 to 17 years of age suffering from bipolar disorder.

The U.S. Food and Drug Administration (FDA) has given priority review status to the drug Abilify which is manufactured by Bristol-Myers Squibb and Otsuka Pharmaceutical.

Priority review status is given to products which could offer an improvement in the treatment, diagnosis or prevention of a disease over products already on the market; the review process as a rule takes six months.

The priority review has been prompted by promising research results following a study involving 296 pediatric patients with bipolar l disorder; over a 30 week period Abilify was seen to be both safe and effective.

The FDA has accepted the drug company's supplemental approval application for young people between 10 and 17 years of age, who are diagnosed with certain types of bipolar I disorder.

Although doctors are allowed to prescribe drugs for off-label uses, drug companies are prohibited from marketing them for uses that have not been approved by the FDA.

Earlier this year Bristol-Myers and associates paid a fine of more than $515 million to settle federal and state investigations into their drug marketing and pricing practices; illegally promoting the sale of Abilify for pediatric use was part of that case.

Bipolar disorder, which is also known as manic-depressive illness, is a brain disorder that causes extreme mood changes which affect energy and the ability to function.

Such mood swings can result in damaged relationships, poor job or school performance, and even suicide.

Millions of people worldwide have the disorder which usually develops in late adolescence or early adulthood; however some people have their first symptoms during childhood, and some develop them late in life.

Many people suffer for years before bipolar is properly diagnosed and treated.

Anti-psychotic medications such as Abilify have been noted to cause weight gain and increase the risk of diabetes.