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9/19/2000

Oral Mesalamine Prodrug Approved for Active Ulcerative Colitis

Jane L. Miller

Salix Pharmaceuticals has received approval to market balsalazide disodium (Colazal) oral capsules for treatment of mildly to moderately active ulcerative colitis. Salix expects to introduce Colazal in the first quarter of 2001.

Balsalazide, a prodrug, is delivered to the colon intact. There it is cleaved enzymatically to produce mesalamine (5-aminosalicylic acid). 

The recommended dosage of balsalazide disodium is 2.25 g three times daily for eight weeks. This dosage delivers 2.4 g of mesalamine each day to the colon. In clinical trials, this dosage was associated with symptomatic improvement in patients with active mild or moderate ulcerative colitis. Treatment was continued for up to 12 weeks. 

Balsalazide is not labeled for use as maintenance therapy. 

The most common adverse events reported by patients taking balsalazide are headache, abdominal pain, nausea, and diarrhea. 

Colazal will be available as 750-mg capsules in bottles of 280. 

Click here to view the product labeling (in PDF).