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news.Salix Pharmaceuticals has submitted to the FDA a new drug application seeking approval to market granulated mesalamine. Salix believes this application will be subject to a 10-month review period.
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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.”