Accompanying the approval of VIBERZI, the U.S. FDA has also approved another drug, Xifaxan (rifaximin) for the treatment of IBS-D (irritable bowel syndrome with diarrhea).  Xifaxan is marketed by Valeant, a pharmaceutical company based in Montreal, Canada.  Xifaxan is an orally available, semi-synthetic antibiotic previously approved by the FDA for the treatment of hepatic encephalopathy (HE) and travelers’ diarrhea (TD) caused by noninvasive strains of E. coli.  The safety and efficacy of Xifaxan for the treatment of IBS-D was established by three clinical trials with close to 1900 patients.  Currently, there is no one medication that can control the symptoms for all patients suffering from IBS-D.  The approval of two new therapies provides additional treatment options for patients and their doctors.

 

References:

  1. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm448328.htm
  2. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021361s012lbl.pdf
  3. http://www.salix.com/products/xifaxan550/
  4. http://ir.valeant.com/investor-relations/news-releases/news-release-details/2015/Salix-Announces-FDA-Approval-of-Xifaxan-550-mg-for-the-Treatment-of-IBS-D-Irritable-Bowel-Syndrome-with-Diarrhea/default.aspx