Balsalazide: a novel 5-aminosalicylate prodrug for the treatment of active ulcerative colitis.
BACKGROUND
5-Aminosalicylate (5-ASA) agents are the mainstay of oral therapy for ulcerative colitis (UC). Balsalazide, a prodrug of 5-ASA, has recently been approved for the treatment of UC.


OBJECTIVE
To summarize current data on balsalazide and to discuss its impact on management of UC.


METHODS
A systematic review of published literature was performed on PubMed using the search terms 'Balsalazide' and 'Colazal(TM)'. The Cochrane database was also reviewed.


RESULTS
Balsalzide, a 5-ASA prodrug, ulilizes azoreduction by colonic bacteria to achieve a sustained release of active 5-ASA throughout the colon. A recent clinical trial has demonstrated balsalazide 6.7 g/day to be superior to placebo in inducing remission in symptomatic UC. The drug is well tolerated with a safety profile comparable to other oral 5-ASA agents. The current data suggests that symptomatic remission occurs with both greater swiftness and greater frequency when compared with mesalamine.


CONCLUSIONS
Balsalazide is approved for the treatment of mild-to-moderate active UC. It is efficacious for the induction of remission in mild to moderate UC and has a favorable safety profile, with the added advantages of greater efficacy of remission induction and rapidity of onset.
Wiggins
Jon Brendan
JB
Stony Brook University Medical Center, Division of Gastroenterology and Hepatology, HSC, T17, Rm 060, SUNY, Stonybrook, NY 11794-8173, USA.
Rajapakse
Ramona
R
D002986:Clinical Trials as Topic; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D019804:Mesalamine / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D010659:Phenylhydrazines / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D011355:Prodrugs; D012074:Remission Induction / Q000379:methods
D003692:Delayed-Action Preparations; D005765:Gastrointestinal Agents; D010659:Phenylhydrazines; D011355:Prodrugs; D019804:Mesalamine; C038637:balsalazide