Wednesday, August 8, 2012

Crohn's and Xifaxan (Rifaximin) and New Venture for Salix

It was recently announced that Salix Pharmaceuticals will pay $25 million in addition to $10 million ($35 million total) to Alfa Wassermann if Xifaxan (rifaximin) is approved for Crohn’s. Currently, Xifaxan is FDA approved but only for traveler’s diarrhea.

In this trial when patients were given Xifaxan and 70% of patients who were not on steroids went into remission. In this very recent study (2011) when 800 mg of Xifaxan was administered to Crohn’s patients twice a day for 3 months (12 weeks) 62% of patients went into remission which is very good and better than biologics like Humira and Remicade given rifaximin has few side effects.

 Xifaxan has been around since 1987 to treat traveler’s diarrhea (approved by FDA in 1998).  One interesting thing I didn’t know was the Xifaxan does not build up antibiotic resistance like other drugs. Also interesting is that the drug is helpful for people with irritable bowel syndrome (IBS). I was diagnosed with IBS in February the same year I was diagnosed with Crohn’s (got diagnosed with Crohn’s in December of that same year). I have always wondered if there was a connection if any. My gastro prescribed hyoscyamine for the IBs and all I really had was a pain in my side. I really just had a pain in my right side.  Right before I got Crohn’s my internist said I had bronchitis and gave me Levaquin, Prednoise, and all in October. I remember with the bronchitis feeling really tired and often just laid on the couch studying cause I really didn’t feel like getting out of bed.  I started having diarrhea right before I took the Levaquin (for a while both my father and I believed this is what was causing me to get Crohn’s). I came home the day before Thanksgiving feeling so tired I honestly don’t remember how I drove to the airport I was so tired.

Honestly, I hope that Xifaxan gets approved for Crohn’s. I have talked before on this blog about how the FDA actually harms people by holding up drugs in development to make sure they are deemed “safe” and effective. I would rather have a system that just looks at the safety and lets patients decide whether or not the drugs are effective. People are different. What works for one individual may not work for another individual. Having clinical tests on small groups of people is meaningless if other people who weren’t even in the group could benefit. Xifaxan seems to be a drug with large benefits and low costs yet the FDA still has not approved it while hundreds of thousands of people suffer every day from Crohn’s. 

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