Salix Pharmaceuticals announced that the company has held a pre-New Drug Application (NDA) meeting with the FDA to discuss the proposed NDA for Xifaxan (rifaximin tablets) for the treatment of patients with non-constipation irritable bowel syndrome (non-C IBS). Salix has completed its Phase 3 TARGET 1 and TARGET 2 trials, designed to investigate the utility of Xifaxan in non-C IBS by assessing adequate relief of IBS symptoms, adequate relief of IBS-related bloating and other endpoints (eg, abdominal pain and stool consistency) in patients ≥18 years of age. The primary endpoint of TARGET 1 and TARGET 2 was the proportion of subjects who achieved adequate relief of IBS symptoms for at least two weeks during the first four weeks of the 10-week follow-up phase.
The NDA submission for Xifaxan for the treatment of non-constipation irritable bowel syndrome is anticipated during the first half of 2010.
Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens.
For more information call (800) 508-0024 or visit www.salix.com.