Xifaxan rifaximin regulatory update

Salix submitted a response to an FDA complete response letter for an sNDA for Xifaxan rifaximin 550 mg tablets to treat irritable bowel syndrome with diarrhea (IBS-D). Salix's response includes data from the Phase III TARGET 3 trial evaluating retreatment with thrice-daily 550 mg Xifaxan in IBS-D patients. In July, the company reported that Xifaxan met the primary endpoint in the trial (see BioCentury, July 14). FDA issued the complete response letter in 2011 requesting retreatment information for the non-absorbed broad-spectrum antibiotic (see BioCentury, March 14, 2011). ...