This application is based upon results from two large, multicenter, six-month, double-blind, randomized, placebo-controlled studies. These studies demonstrated a statistically significantly greater proportion of ulcerative colitis patients dosed once-a-day with 1.5 grams of granulated mesalamine remained relapse-free over six months of treatment than patients dosed with placebo.
Bill Forbes, vice president, R&D, Salix, said: “This granulated mesalamine formulation combines an enteric pH-dependent coating, which provides for delayed release, and a polymer matrix core, which provides for extended release. This combination of delayed release followed by extended release is intended to provide reliable and effective delivery of mesalamine, or 5-ASA, beginning in the small bowel and continuing throughout the colon.”