Salix reports successful results in IBS treatment trial

RALEIGH, N.C. Salix Pharmaceuticals on Monday announced the successful outcome of two Phase 3, randomized, double–blind, placebo–controlled, multicenter trials designed to evaluate the efficacy and safety of Xifaxan (rifaximin 550 mg) in the treatment of patients with non–constipation irritable bowel syndrome.

In each trial Xifaxan versus placebo treated patients demonstrated a statistically significant improvement for the primary endpoint of the adequate relief of IBS symptoms as assessed over one month following completion of a 14–day course of therapy.

"We are extremely pleased with the outcome of our pivotal Phase 3 trials of rifaximin in the treatment of non–constipation irritable bowel syndrome," stated Bill Forbes, SVP and chief development officer, Salix Pharmaceuticals. "Irritable bowel syndrome, characterized by abdominal pain, bloating and altered bowel habits, is one of the most common chronic medical conditions. Non–constipation IBS comprises the most common forms of IBS by including patients that have either diarrhea– predominant or diarrhea–constipation alternating symptoms.”

The company is targeting to submit the NDA during the first half of 2010.