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Food & Drug Administration (FDA). A decision from the FDA regarding the approval status of the drug for the treatment of IBS- D is expected in early 2. Salix Pharmaceuticals announces Initiation of Clinical Trial to Assess Repeat Treatment with Rifaximin. July 1, 2. 01. 4 – Salix Pharmaceuticals reported positive results from the TARGET 3 – Phase 3 study to evaluate the efficacy and safety of repeat 1. IBS with diarrhea (IBS- D) in people who responded to an initial 1. Compared to placebo, subjects treated with rifaximin showed statistically significant improvement in IBS- related abdominal pain and stool consistency during the 4 week treatment- free follow- up period in the double blind repeat treatment phase. Salix is seeking marketing approval from the FDA for rifaximin as a treatment option for irritable bowel syndrome with diarrhea. February 2. 1, 2. Salix Pharmaceuticals announced the initiation of TARGET 3 – a Phase 3 study to evaluate the efficacy and safety of repeat treatment with Xifaxan (rifaximin) for irritable bowel syndrome with diarrhea (IBS- D). The study will involve approximately 8. IBS- D who have previously responded to an initial treatment course of rifaximin 5. In this study, these patients will take a repeat treatment of 5. TARGET 3 is randomized, double- blind, placebo- controlled and will be conducted in approximately 2. United States. FDA Approves new Clinical Trial Looking at Repeat Treatment with Rifaximin. November 1. 6, 2. Salix Pharmaceuticals announced that the U. S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee supported the Salix/FDA developed proposed design of a clinical trial to evaluate the safety, efficacy and durability of response with repeat treatment cycles of Xifaxan (rifaximin) for irritable bowel syndrome with diarrhea (IBS). About 2. 4 months could be required for the company to complete the trial and secure an FDA decision regarding approval. FDA Delays Approval Consideration of Rifaximin. March 8, 2. 01. 1 - Salix Pharmaceuticals confirmed that the U. S. Food and Drug Administration (FDA) wants more information about rifaximin. The FDA is not ready to grant a new marketing approval for rifaximin for the treatment of non- constipation irritable bowel syndrome (Non- C IBS) and IBS- related bloating. The FDA may require that another clinical trial be performed, which could take years to complete. Salix said it will request a meeting to discuss this with the FDA. Rifaximin is currently approved by the FDA for treatment of travelers’ diarrhea (under the trade name of Xifaxan. The FDA had originally set a target date of March 7, 2. Priority Review for expanding the uses of rifaximin to include treatment of IBS. The statistically significant weekly findings in the primary endpoint and key secondary endpoint noted above were supported by daily findings in the secondary endpoints of global IBS symptoms, bloating, stool consistency and abdominal pain and discomfort. Additionally, the NEJM publication includes results of an analysis of a composite endpoint of abdominal pain or discomfort and loose or watery stools as outlined in the March 2. FDA Guidance for Industry relating to the clinical evaluation of products for treatment of IBS. The safety profile of rifaximin was similar to that of placebo. Rifaximin is a gut- selective antibiotic with negligible systemic absorption and broad- spectrum activity in vitro against both gram- positive and gram- negative pathogens. Food and Drug Administration (FDA) for treatment of travelers’ diarrhea (under the trade name of Xifaxan. It is not yet approved by the FDA for the treatment of IBS. The FDA has set a target date of March 7, 2. Priority Review for expanding the uses of Xifaxan (rifaximin) to include treatment of non- constipation irritable bowel syndrome (Non- C IBS) and IBS- related bloating. Salix Pharmaceuticals Announces FDA Acceptance For NDA Priority Review For Xifaxan. For Treatment Of Non- Constipation Irritable Bowel Syndrome August 9, 2. Salix announced the U. S. Food and Drug Administration (FDA) accepted for Priority Review the Company’s efficacy supplement to the New Drug Application (NDA) for XIFAXAN. The safety profiles were similar between XIFAXAN 5. Salix has requested Priority Review for this application. By regulation, the FDA should determine the review classification for this application within the 6. Phase 3 Studies Report Rifaximin Shows Promise for Treatment on Non- Constipated IBSNEW ORLEANS, LA, May 3, 2. Results from two Phase 3 clinical trials involving 1,2. IBS) were presented at the annual Digestive Disease Week (DDW) meeting in May 2. Results from the multiple center studies indicated that 5. Rifaximin, taken orally 3 times a day for 1. IBS symptoms over a period of 1. Adequate relief was demonstrated in a statistically greater proportion of patients on the drug compared to placebo. Improvement was reported in overall IBS symptoms and IBS specific symptoms of bloating, stool consistency and abdominal pain and discomfort. Rifaximin is a broad- spectrum antibiotic that targets bacterial overgrowth in the small intestine. It is only slightly absorbed in the gut. While rifaximin is generally well tolerated, as with all antibiotics side- effects may occur. It is currently approved by the U. S. Food and Drug Administration (FDA) for treatment of travelers’ diarrhea (under the trade name of Xifaxan. It is not yet approved by the FDA for the treatment of IBS. Rifaximin is marked by Salix Pharmaceuticals. Salix Presents New Phase II Data Evidence Demonstrating the Clinical Utility of Rifaximin in Irritable Bowel Syndrome (IBS)Results Presented at American College of Gastroenterology Annual Meeting Demonstrate Quality of Life Benefits and IBS Symptom Severity as Predictor of Clinical Response. ORLANDO, FLA., October 6, 2. Salix Pharmaceuticals, Ltd. Data presented at the annual meeting of the American College of Gastroenterology (ACG) showed that patients treated with rifaximin demonstrated that the severity of baseline IBS symptoms of abdominal pain and bloating predicted clinical response to rifaximin and demonstrated statistically greater clinical improvement in quality of life compared with placebo. Chey, MD, professor of medicine in the Division of Gastroenterology at the University of Michigan, and director of the Gastrointestinal (GI) Physiology Laboratory at the University of Michigan Medical Center. Chey and colleagues reported that a 2- week course of rifaximin (1. 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