BioCentury
ARTICLE | Clinical News

Salix reports Phase III IBS-D data

July 2, 2014 12:21 AM UTC

Salix Pharmaceuticals Inc. (NASDAQ:SLXP) said Xifaxan rifaximin met the composite primary endpoint in a Phase III trial in about 800 patients with irritable bowel syndrome with diarrhea (IBS-D). The endpoint was a greater proportion of responders based on both IBS-related abdominal pain and stool consistency during a four-week treatment-free follow-up period vs. placebo.

FDA asked for the retreatment trial in a March 2011 complete response letter. Salix plans to resubmit an sNDA for Xifaxan as a retreatment for IBS-D, but could not be reached for a time frame (see BioCentury Extra, March 8, 2011). ...