Xifaxan rifaximin: Additional Phase III data

Additional data from the double-blind, international Phase III TARGET 3 trial in 636 patients with IBS-D showed that retreatment with thrice-daily 550 mg oral Xifaxan met the secondary composite endpoint of a greater proportion of responders based on both IBS-related abdominal pain and stool consistency during the first 6-week treatment phase and who continued to respond without recurrence through week 12 independent of any additional treatment vs. placebo (p=0.0419). A treatment phase comprised a 2-week treatment period followed by a 4-week treatment-free follow-up period.

Xifaxan also met the secondary composite endpoint of a greater proportion of responders based on both IBS-related abdominal pain and stool consistency during the first treatment phase and who continued to respond without recurrence through week 6 following the second repeat treatment phase vs. placebo (p=0.0068). Additionally, data from stool samples of about 100 randomly selected patients in the trial showed no disturbance of fecal microbiota. Furthermore, there was no evidence of cross-resistance to non-rifamycin antibiotics in isolates grown from either stool or skin swab cultures. ...