Disodium azodisalicylate. American College of Gastroenterology Committee on FDA-Related Matters.

For more than four decades, sulfasalazine has been administered for the treatment of ulcerative colitis. Unfortunately, the successes achieved by this agent in the therapy of the acute attack and in the prolongation of the remission period have not been without a concomitant history of significant side effects. This two-edged sword property is based on the two released components of sulfasalazine. The prevailing evidence indicates that the therapeutic effect resides in the 5-ASA moiety, while most of the adverse actions are ascribed to its sulfapyridine portion. Sodium azodisalicylate was synthesized with the expectation that the elimination of the sulfapyridine group would create a drug retaining sulfasalazine's therapeutic efficacy, but associated with less toxicity. Clinical trials are presently addressing this hypothesis.