Salix Pharmaceuticals, Ltd. has announced that it has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) seeking approval to market granulated mesalamine. Salix believes this application will be subject to a 10-month review period.
“This application is based upon results from two large, multicenter, 6-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 6 months of treatment than patients dosed with placebo,” stated Bill Forbes, Pharm. D., Vice President, Research and Development, Salix.
“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 formulation is designed to provide for the distribution of the active ingredient beginning in the small bowel and continuing throughout the colon.
Additionally, we believe that granulated mesalamine, if and when approved by the FDA, will be the only pH-dependent product in its class that begins to release at a pH of 6.0. 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.”