For Now, FDA Blocks Approval Of Xifaxan for Usage By Those With Irritable Bowel Syndrome.
Salix Pharmaceuticals confirmed on Tuesday(March 8th, 2011) that approval of their drug Xifaxan(aka Rifaxamin) for use in those with Irritable Bowel Syndrome was put on hold by the FDA for the time being. The FDA stated that they did not feel the drug was ready for approval in it’s current form & are requesting Salix provide them with additional information about the drug before they’ll reconsider. Salix’s stock price took an immediate hit on the news & has stayed down by about 25% since.Salix has not given up hope yet. They have stated they will request a meeting with the FDA within the next 30-days to discuss the issue further. Salix will provide further updates on their efforts for FDA approval sometime in May.
Xifaxan is already approved for treatment of conditions such as travelers diarrhea or neurological issues related from liver problems. It is essentially an antibiotic that is not easily absorbed by the intestinal tract, thus it does well at killing off bacterial overgrowth which may have setup shop there. I have already stated my opinion on Xifaxan in the past. I personally have not been very impressed with it’s trial results, but it might be of some help to some people with Irritable Bowel Syndrome. It’ll be interesting to see how Salix regroups.