Salix Pharmaceuticals (SLXP) reports positive results from a Phase 3 clinical trial evaluating the safety and efficacy of Xifaxan (rifaximin) in patients with irritable bowel syndrome with diarrhea (IBS-D). In the trial, patients received rifaximin 550 mg TID (3x/day) for 14 days. A statistically significant greater proportion of the test group responded to repeat treatment compared to placebo as assessed by the primary endpoint of IBS-related abdominal pain and stool consistency during the four-week treatment-free follow-up period.
The company intends to file an sNDA for the expanded indication of IBS-D. Xifaxin is currently approved as a treatment for the reduction in risk of overt hepatic encephalopathy recurrence in patients at least 18 years of age.
SLXP shares are up 10% premarket on modest volume.