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. Continue reading “FDA Puts Brakes On Approval Of Salix’s Xifaxan For Irritable Bowel Syndrome” »
I reported about a study on Rifaximin a few months ago. I was not that impressed by the results at that time. Well there has been a new study released on Rifaxmin showing pretty much the same unimpressive results. The facts are still that only about 11% saw benefit over placebo. That difference seems even more dubious what with the recent placebo study showing a similar level of efficacy. Who knows if the Rifaximin is really doing anything at all? Additionally patients are only tracked for 10-weeks, there is no information for what happens after that. It appears I am not alone in my concerns regarding the study. If you check out the comments on the study you’ll find there are a few doctors chiming in with their concerns:
“Here we go on another journey into a poorly supported area of new treatment…….this article barely shows a statistically signifincant difference, and certainly not a convincing one.” – MICHAEL ELIASTAM, MD
“This study is problematic in several ways, not least of which is the long list of companies involved, and somehow attached to the trial’s outcome.” – DAVID GLUCK, MD
“As a practicing gastroenterologist for 12 years as well as an IBS sufferer for almost 40, I realized long ago that we cannot treat IBS with a pill and that IBS is for life, and not for 10 weeks. I have been following Dr. Pimental’s studies for years, and I have yet to see anything last as long as the stress and psychological manipulation techniques that I and many others have been advocating for years.” – KIMBERLY CUSATO, MD
So buyer beware, Rifaximin may not be all it’s cracked up to be or what the hype my have you believe.
There has been some recent news on the drug Rifaximin(brand name XIFAXAN) showing some promising results for treating Irritable Bowel Syndrome. Rifaximin is an anti-biotic that is poorly absorbed by the body. What this means is that most of it stays in the gut where it attacks bacteria. The idea here is that harmful bacteria create toxins in the body causing neurocognitive and neuromuscular dysfunction. By using Rifaximin you can kill off these bacteria and hopefully restore the gut to it’s regular functions. Continue reading “News: Rifaximin For Irritable Bowel Syndrome” »