Glaxo Wellcome plans to study alosetron in children and adolescents with irritable bowel syndrome.
At the advisory committee hearing, Dr. George Dukes of Glaxo Wellcome said that the company had submitted a proposal to the Food and Drug Administration to study alosetron in children aged 611 and in adolescents, and hopes to begin studies in early 2000.
Dr. George D. Ferry, the pediatric gastroenterologist on the FDA's GI drugs advisory panel, said that there "will be a real interest in using this drug in children." Pediatric gastroenterologists struggle with how to treat young patients with IBS, he said at the hearing.
"It's not a very common problem in pediatrics, but it's definitely there," said Dr. Ferry of Texas Children's Hospital, Houston. The incidence of IBS in the pediatric population is much lower than in adults and varies by age, but is most clearly defined in those aged 13 and older.
The implications and severity of IBS "are very much the same" in children as in adults, he added.
The potential for using new drugs in children is often raised now at FDA hearings dealing with drugs that are used to treat adults, as part of an initiative to improve pediatric labeling of drugs.
The Food and Drug Administration Modernization Act, which went into effect in November 1998, created a powerful financial incentive for manufacturers to study their products in children: Companies receive a 6-month extension on the drug's patent if they provide acceptable pediatric data on the product.
COPYRIGHT 2000 International Medical News Group
COPYRIGHT 2001 Gale Group
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