Salix announced that the FDA has granted marketing approval for Giazo (balsalazide disodium) tablets for the treatment of mildly to moderately active ulcerative colitis in male patients >18 years old. Balsalazide disodium is a prodrug of mesalamine that acts locally on the colonic mucosa rather than systemically. It diminishes inflammation by blocking production of arachidonic acid metabolites in the colon. It works independently of pH levels to help induce remission.

A double-blind, placebo-controlled, multicenter trial was conducted in 250 adult patients (49% male) with mildly to moderately active ulcerative colitis.  The primary efficacy endpoint was the proportion of patients that achieved clinical improvement and improvement in the rectal bleeding subscale of the modified Mayo Disease Activity Index (MMDAI) at the end of 8 weeks of treatment.

Study results showed that differences were statistically significant in the overall population; however, these effects were entirely driven by the results in the male subpopulation. After adjusting for multiplicity, statistically significant differences were also seen in the male patients for clinical remission (35% with Giazo vs. 13% for placebo) and for mucosal healing (52% with Giazo vs. 20% for placebo). Effectiveness of Giazo was not demonstrated in the female subpopulation in the clinical trial.

Salix also manufactures Apriso (mesalamine) extended-release capsules for the maintenance of remission of ulcerative colitis in adults.

Giazo tablets are available in a 1.1g strength in 180-count bottles.

For more information call (800) 508-0024 or visit