SALIX'S COLAZAL APPROVED FOR PEDIATRIC PATIENTS

The FDA ha approved Salix Pharmaceuticals' Colazal (balsalazide disodium) for the treatment of mildly to moderately active ulcerative colitis in patients 5 to 17 years of age. The condition affects about 5 per 100,000 pediatric patients in the United States each year. Pediatric use of Colazal was previously granted orphan drug status, which provides financial incentives for firms that develop therapies for diseases affecting fewer than 200,000 patients a year.

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 eight weeks of treatment. In this study, 45 percent of the children on the higher dose and 37 percent on the lower dose showed clinical improvement.

Colazal is the only 5-ASA approved for use in pediatric patients, according to the company. In September the company won approval for a labeling change to provide for the administration of Colazal sprinkled over applesauce, which would also help in prescribing the drug to pediatric patients, the company said.