News Releases

Salix Presents Rifaximin Phase 3 Study Results for Irritable Bowel Syndrome with Diarrhea at Digestive Disease Week

WASHINGTON, June 3, 2018 /PRNewswire/ -- Salix Pharmaceuticals, Ltd. ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases, will present Phase 3 rifaximin study data at Digestive Disease Week (DDW) in Washington, D.C., from June 2-5, 2018.

Salix Pharmaceuticals, Ltd. Logo (PRNewsfoto/Salix Pharmaceuticals, Ltd.)

"We are proud to showcase this data at DDW to leading gastroenterologists and researchers to continue to reiterate the benefits of rifaximin for patients with irritable bowel syndrome with diarrhea (IBS-D)," said Mark McKenna, senior vice president and general manager, Salix Pharmaceuticals. "Our customers, including both patients and healthcare professionals, are our top priority and we will continue researching to ensure their needs are met."

The complete schedule of oral and poster presentations that will be presented on rifaximin data at DDW on June 3 includes:

  • Pimentel, Mark. Lack Of Development Of Opportunistic Infections, Including Candidiasis, In Patients With Diarrhea-Predominant Irritable Bowel Syndrome Receiving Repeat Treatment With Rifaximin (session #2655, Room 201, 5:00pm5:15pm)
  • Pimentel, Mark. Rifaximin Repeat Treatment For Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) And Impact On Clostridium Difficile Infection Development (poster #Su1195, Hall C, 12:00pm2:00pm)
  • Weinstock, Leonard. Characterization Of Long-Term Rifaximin Responders From A Phase 3, Randomized, Double blind, Placebo-Controlled Repeat Treatment Trial For Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) (poster #Su1190, Hall C, 12:00pm2:00pm)
  • Lacy, Brian. Efficacy Of Rifaximin On Bloating In Patients With Diarrhea–Predominant Irritable Bowel Syndrome (IBS–D): A Pooled Analysis Of Three Phase 3, Randomized, Placebo–Controlled Trials (poster #Su1191, Hall C, 12:00pm2:00pm)
  • Lembo, Anthony. Efficacy of Rifaximin in Patients with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D) and Prior Use of IBS Medications (poster #Su1194, Hall C, 12:00pm2:00pm)

"The data presented at DDW continues to support the efficacy of rifaximin for patients with IBS-D," said Mark Pimentel, M.D., professor of Medicine and executive director of the Medically Associated Science and Technology Program, at Cedars-Sinai, in Los Angeles, CA. "I'm encouraged by these results that help us understand the extent to which Clostridium difficile (C. Diff) may occur with Xifaxan."  

About XIFAXAN

XIFAXAN® (rifaximin) 550 mg tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

IMPORTANT SAFETY INFORMATION

  • XIFAXAN is not for everyone. Do not take XIFAXAN if you have a known hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN.
  • If you take antibiotics, like XIFAXAN, there is a chance you could experience diarrhea caused by an overgrowth of bacteria (C. difficile). This can cause symptoms ranging in severity from mild diarrhea to life-threatening colitis. Contact your healthcare provider if your diarrhea does not improve or worsens.
  • Talk to your healthcare provider before taking XIFAXAN if you have severe hepatic (liver) impairment, as this may cause increased effects of the medicine.
  • Tell your healthcare provider if you are taking drugs called P-glycoprotein and/or OATPs inhibitors (such as cyclosporine) because using these drugs with XIFAXAN may lead to an increase in the amount of XIFAXAN absorbed by your body.
  • In clinical studies, the most common side effects of XIFAXAN in IBS-D were nausea (feeling sick to your stomach) and an increase in liver enzymes.
  • XIFAXAN may affect warfarin activity when taken together. Tell your healthcare provider if you are taking warfarin because the dose of warfarin may need to be adjusted to maintain proper blood-thinning effect.
  • If you are pregnant, planning to become pregnant, or nursing, talk to your healthcare provider before taking XIFAXAN because XIFAXAN may cause harm to an unborn baby or nursing infant.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/  or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact: 
Salix Product Information Call Center  
Phone: 1-800-321-4576  
Fax: 1-510-595-8183  
Email: salixmc@dlss.com

Please click here for full Prescribing Information.

About Salix

Salix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world and is committed to the prevention and treatment of gastrointestinal diseases. For almost 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix, a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc., is headquartered in Bridgewater, New Jersey.

The Xifaxan 550 mg product and the Xifaxan trademark are licensed by Alfasigma S.p.A.to Salix Pharmaceuticals or its affiliates. SAL.0070.USA.18

SOURCE Salix Pharmaceuticals, Ltd.

For further information: Karen Paff, Karen.Paff@salix.com, 908-927-1190