www.fdanews.com/articles/98058-salix-announces-results-from-ulcerative-colitis-study
Salix Announces Results From Ulcerative Colitis Study
September 5, 2007
Salix Pharmaceuticals has completed the first 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 ulcerative colitis remission.
Results from the 300–subject, multicenter, six-month, double-blind, randomized, placebo-controlled study indicate that a greater proportion of subjects receiving a 1.5-g dose of granulated mesalamine daily remained relapse free compared with patients dosed with placebo.
Salix acquired rights to market granulated mesalamine in the U.S. from Germany’s Dr. Falk Pharma, which markets granulated mesalamine in Europe and Australia under the trade name Salofalk Granu-Stix.