Salix Pharmaceuticals, Ltd has announced the successful completion and outcome of the second of two phase III registration trials to evaluate the safety and efficacy of the company's new granulated Mesalamine product currently, under development for the maintenance of remission in patients with ulcerative colitis.
Results from the study indicate that a statistically significantly greater proportion of subjects dosed once a day with 1.5 grams of granulated mesalamine remained relapse-free over six months of treatment than patients dosed with placebo.
Commenting on the study, Bill Forbes, Pharm.D., vice president, research and development, Salix Pharmaceuticals, stated, "The outcome of this second, 300 subject, multi centre, six month, double blind, randomized, placebo controlled study confirms the results of the study we reported in September 2007. The results of this second study again demonstrate the utility of our novel delayed and extended release formulation of mesalamine, dosed once a day in this study, to successfully maintain remission in ulcerative colitis patients. We continue to anticipate a December 2007 NDA submission for this product".
Salix acquired rights to market granulated mesalamine in the US from Dr Falk Pharma GmbH of Freiburg, Germany. Dr Falk Pharma markets granulated mesalamine in Germany and other European countries, as well as Australia, under the trade name Salofalk Granu-Stix. The application to market Salofalk Granu Stix is currently under regulatory review for additional non EU countries.