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Colitis Drug Gets FDA Approval for Children and Teens

Colazal gets go-ahead for pediatric use under Orphan Drug program

THURSDAY, Dec. 21 (HealthDay News) -- The U.S. Food and Drug Administration has approved the drug Colazal (balsalazide disodium) to treat ulcerative colitis in children aged 5 to 17 under its Orphan Drug program, a scheme to encourage drug companies to develop therapies that affect fewer than 200,000 people a year. The drug, manufactured by Salix Pharmaceuticals, Inc. of Morrisville, N.C., has already been approved for use in adults with mildly to moderately active ulcerative colitis.

The approval for pediatric use was made possible by a clinical trial of 68 patients who were randomized to receive a daily dose of 6.75 grams or 2.25 grams of Colazal for eight weeks.

Clinical improvement was seen in 45 percent of those on the 6.75 gram dose and 37 percent of those on the 2.25 gram dose. Adverse events included headache and gastrointestinal symptoms, and were more prevalent in the low-dose group.

"Ulcerative colitis is a debilitating and frequently painful disease for which there has been no satisfactory pediatric treatment," said Douglas C. Throckmorton, M.D., deputy director of FDA's Center for Drug Evaluation and Research, in a statement. "[This] is another example of the great benefits that the Orphan Drug program provides for patient populations that are too small to justify the large investment in new drug development," he notes.

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