Salix Gets FDA Approval For Colazal in Pediatric UC Patients
This article was originally published in The Pink Sheet Daily
Executive Summary
Colazal becomes first 5-ASA approved for pediatric ulcerative colitis, firm says.
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Salix Pharmaceuticals is positioning Colazal (balsalazide disodium) as the only 5-aminosalicyclic acid product for pediatric ulcerative colitis, following FDA's Dec. 20 approval of the supplemental indication. The anti-inflammatory was approved in 2000 for treatment of mildly to moderately active ulcerative colitis in adults. With the supplemental approval, the product will now be available to patients five to 17, as well, in 750 mg capsules, Salix noted. Other 5-ASA's on the market include Shire's Pentasa (mesalamine) and Axcan's mesalamine suppository product Canasa . In September, FDA said it would delay review of an NDA for Shire's Mesavance (mesalamine tablets) for UC while the agency evaluates supplemental Phase I pharmacokinetic data (1 (Also see "Shire’s Mesavance User Fee Date Extended To Jan. 21" - Pink Sheet, 8 Sep, 2006.)). Colazal's sNDA approval was based on a randomized, multicenter study in 68 children who received either 6.75 grams or 2.25 grams of Colazal per day for eight weeks. In the study, 45 percent of patients on the higher dose and 37 percent on the lower dose showed clinical improvement in rectal bleeding and the appearance of gastrointestinal mucosa, FDA said. The most common side effects included headache, abdominal pain, vomiting and diarrhea, according to the agency. Salix has orphan drug status for the pediatric indication. Salix told "The Pink Sheet" DAILY it will promote the supplemental indication to pediatric gastroenterologists using its 96-member sales force already detailing the drug. "This approval, combined with the September labeling approval which provides for the administration of Colazal as sprinkled over applesauce, should provide gastroenterologists with an option that increases their level of comfort and confidence in treating children," CEO Carolyn Logan said. The Raleigh, N.C.-based firm is also developing a Colazal tablet formulation, which it hopes to file with FDA in the second half of 2007. -Daniel Fowler ([email protected]) |