Date: Feb 21, 2012 Author: Jason deBruyn Source: bizjournals (
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Salix Pharmaceuticals said Tuesday that it will run more tests in hopes of showing that its lead drug, Xifaxan, can help subjects with Irritable Bowel Syndrome with diarrhea.
In November, the Food and Drug Administration, which regulates pharmaceuticals and medical devices, questioned Xifaxan's effectiveness in treating the bowl disorder, but agreed to meet with Salix (Nasdaq: SLXP) to hear its perspective.
Now Salix will run new tests to see if Xifaxan, which was on pace to hit $350 million in sales last year, can be advertised for the new indication, which would make it the first antibiotic approved for IBS with diarrhea.
Xifaxin is already marketed for the treatments of hepatic encephalopathy — a condition that occurs when a damaged liver cannot remove the toxins that a healthy liver normally would — and traveler's diarrhea.
Jason deBruyn covers Health Care, Higher Education, Nonprofits. Follow him on Twitter @jasondebruyn.