FDA Approves Colazal for Children and Teens With Mildly to Moderately Active Ulcerative Colitis

The Food and Drug Administration (FDA) today approved Colazal (balsalazide disodium) for the treatment of mildly to moderately active ulcerative colitis in patients 5 to 17 years of age. The condition is a type of inflammatory bowel disease which causes inflammation of the colon and rectum and affects about 5 per 100,000 pediatric patients in the United States each year. Pediatric use of Colazal was granted orphan drug status under FDA’s Orphan Drug program, which provides financial incentives for firms that develop therapies for diseases affecting fewer than 200,000 patients a year.

"Ulcerative colitis is a debilitating and frequently painful disease for which there has been no satisfactory pediatric treatment," said Dr. Douglas C. Throckmorton, Deputy Director of FDA’s Center for Drug Evaluation and Research. "Today’s approval 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."

Colazal had been previously approved for use in adult patients with mildly to moderately active ulcerative colitis. The drug’s safety and effectiveness in children 5 to 17 years of age with mildly to moderately active ulcerative colitis was demonstrated in a multicenter study in 68 patients who were randomized to receive either 6.75 grams or 2.25 grams of Colazal per day for a total of 8 weeks of treatment. In this study, 45% of the children on the higher dose and 37% on the lower dose showed clinical improvement in rectal bleeding and the appearance of the gastrointestinal mucosa.

The most common adverse events associated with the use of Colazal were headache, and symptoms referrable to the gastrointestinal tract, such as abdominal pain, vomiting and diarrhea. The overall rate of drug-related adverse events was higher in the low-dose group as compared to the high-dose group. This may have been due to the lower efficacy seen in the low-dose group.

Colazal is manufactured by Salix Pharmaceuticals, Inc., Morrisville, NC.

Source: FDA Approves Treatment for Children and Teens With Mildly to Moderately Active Ulcerative Colitis

Posted: December 2006


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