Salix Pharmaceuticals, Ltd. announced that the US Food and Drug Administration (FDA) has granted approval of the use of Colazal (balsalazide disodium) capsules 750 mg in paediatric patients between 5 to 17 years of age with ulcerative colitis. Colazal is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis.
Commenting on the approval, Carolyn Logan, President and chief executive officer, stated, "This label expansion sets Colazal apart from all other 5-aminosalicyclic acid, or 5-ASA, products used to treat ulcerative colitis and makes Colazal the only 5-ASA approved for use in paediatric patients. We believe this approval speaks, in large part, to the tolerability of our unique, azo-bonded prodrug formulation of 5-ASA, which is specifically designed for 99 per cent delivery of 5-ASA directly to the colon. We also believe that this approval again demonstrates the Company's commitment to bring gastroenterologists the products needed to provide for all of their patients. This approval, combined with the September labelling 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."
Colazal (balsalazide disodium) capsules 750 mg, is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. Safety and effectiveness of Colazal beyond 8 weeks in children (ages 5-17 years) and beyond 12 weeks in adults has not been established. Colazal was well tolerated in clinical studies. In clinical trials, adult patients reported the following adverse events most frequently: headache (8%); abdominal pain (6%); diarrhoea (5%); nausea (5%); vomiting (4%); respiratory infection (4%); and arthralgia (4%). Withdrawal from therapy due to adverse events was comparable to placebo. In paediatric patients, the following adverse events were most frequently reported: headache (15%); abdominal pain upper (13%); abdominal pain (12%); vomiting (10%); diarrhoea (9%); colitis ulcerative (6%); nasopharyngitis (6%) and pyrexia (6%).
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the company's 150-member gastroenterology specialty sales and marketing team.