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news.Pharmaceutical company Salix has reported the succesful completion of the second of two Phase III registration trials to evaluate the safety and efficacy of granulated mesalamine, which is under development for the maintenance of remission in patients with ulcerative colitis.
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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.
Bill Forbes, vice president of R&D at Salix Pharmaceuticals, said: “The outcome of this second, 300-subject, multicenter, six-month, double-blind, randomized, placebo-controlled study confirms the results of the study 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. They will 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 of Freiburg, Germany.