New Xifaxan 550 Study - Approval Date for IBS-D 3/7/2011
#362797 - 01/06/11 05:08 AM
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XIFAXAN® 550 mg Tablets Demonstrated Significant Acute and Sustained Relief of Irritable Bowel Syndrome Without Constipation According to Findings Published in the New England Journal of Medicine:
http://www.businesswire.com/news/home/20110105006956/en/XIFAXAN%C2%AE-550-mg-Tablets-Demonstrated-Significant-Acute
Cheers.
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ibs-d (pseudo)with pain and bloating
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You can read the full paper here
The accompanying editorial in the NEJM is interesting too. "... the therapeutic gain, with the rates of response to treatment (i.e., adequate relief) ranging between 9 and 12% more with rifaximin than with placebo, is in the lower spectrum of what is considered to be clinically relevant."
And neither rifaximin nor any other antibiotic has been approved for the treatment of IBS by the FDA. The study only addressed IBS-D not IBS-C. It will be interesting to see what the FDA decides in March.
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STABLE: ♂, IBS-D 50+ years - Science of IBS
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I just heard about this antibiotic this morning on NPR on my way to work so I didn't get to hear the whole story..thanks for posting the links Syl
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IBS-D since 2008, female in her 20s
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is that there is no indication in the study that they tested the patients for SIBO, to distinguish between those patients and those without SIBO, to see how results from the antibiotics would differ.
I always get the impression that Dr. Mark Pimentel is trying his best to lump every single person with IBS into the SIBO category, when that just does not logically make sense.
- H
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Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!
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the editorial. SIBO is a problematic diagnosis as explained in paragraph five. Only about 4% of the IBS population is anticipated to have SIBO. On the other hand 9-12% of the IBS-D suffers experienced a significant improvement of symptoms using the antibiotic. So of the 624 individuals that received the antibiotic from 56 to 87 individuals experience significant improvement while only 25 would be expected to have SIBO.
It seems the Pimental and colleague's focus may be moving away from SIBO to the colonic flora. The editor explained it this way "The most likely mode of action of rifaximin is a reduction in overall bacterial load, especially in the large bowel. This may lead to decreased bacterial fermentation and less bloating, possibly in combination with decreased secretion of bacterial products or host responses to bacterial products that contribute to the generation of symptoms."
While non-absorbable antibiotics have potential problems this finding may be bring us closer to an understanding of the causes of IBS. It will interesting to see how the FDA rules in March. 
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STABLE: ♂, IBS-D 50+ years - Science of IBS
The FODMAP Approach to Managing IBS Symptoms
Evidence-based Dietary Management of Functional GI Symptoms: The FODMAP Approach
FODMAP Chart & Cheatsheet
The Role of Food & Dietary Intervention in IBS
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Syl, do you have any updated information on the FDA's pending approval of Xifaxan? In your educated opinion, does it sound like a "lifesaver", or is the success minimal? I have IBS-D.
Thank you.
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I believe the FDA is making a decision next month.
I think the editorial editorial summed up the findings and out look "... the therapeutic gain, with the rates of response to treatment (i.e., adequate relief) ranging between 9 and 12% more with rifaximin than with placebo, is in the lower spectrum of what is considered to be clinically relevant."
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STABLE: ♂, IBS-D 50+ years - Science of IBS
The FODMAP Approach to Managing IBS Symptoms
Evidence-based Dietary Management of Functional GI Symptoms: The FODMAP Approach
FODMAP Chart & Cheatsheet
The Role of Food & Dietary Intervention in IBS
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http://www.reuters.com/article/2011/02/24/salix-idUSL3E7DO19W20110224
Cheers.
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ibs-d (pseudo)with pain and bloating
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Hmmm - looks like it might not get approval given the statement "Citing a telephone call with the U.S. Food and Drug Administration, Salix said the regulator thinks Xifaxan is not ready for approval, and sought additional treatment information". It won't surprise me
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STABLE: ♂, IBS-D 50+ years - Science of IBS
The FODMAP Approach to Managing IBS Symptoms
Evidence-based Dietary Management of Functional GI Symptoms: The FODMAP Approach
FODMAP Chart & Cheatsheet
The Role of Food & Dietary Intervention in IBS
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