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New IBS treatment shows potential in Phase 2 study

2013-08-12
(Press-News.org) Bethesda, MD (August 12, 2013) — Patients with diarrhea-predominant irritable bowel syndrome, or IBS-D, treated with eluxadoline achieved better clinical response and experienced more symptom improvement than those using placebo, according to a recent study in Gastroenterology, the official journal of the American Gastroenterological Association. Eluxadoline, which is currently in phase 3 trials, is under development as a potential treatment for IBS-D.

"There is a critical need for a safe and effective treatment for IBS-D, a disorder affecting approximately 10 to 15 percent of the population in Western counties," said Anthony Lembo, co-study author from Harvard Medical School, Center for Clinical and Translational Research in Gastrointestinal Motility, Beth Israel Deaconess Medical Center, Division of Gastroenterology, Boston, MA. "The results of our study confirm the effectiveness of eluxadoline to decrease abdominal pain and improve stool consistency, without significant risk of constipation, for patients with IBS-D."

This phase 2 study evaluated the effectiveness, safety and tolerability of orally administrated eluxadoline. Researchers randomly assigned 807 adult patients with IBS-D to 5 mg, 25 mg, 100 mg or 200 mg eluxadoline or placebo twice a day for 12 weeks. Patients given eluxadoline had significant symptom improvement with a very low incidence of constipation. Symptom relief and quality of life scores increased with time of treatment.

"Based on these promising results, additional clinical development of eluxadoline is warranted to validate its clinical meaningfulness and to determine what baseline patient characteristics are predictive of clinical response with eluxadoline," added Lembo. "We look forward to seeing how eluxadoline fares in phase 3 trials and hope to end suffering for IBS-D patients searching for an effective treatment."

### IBS can negatively impact an individual's quality of life and result in significant medical costs. Current safe and effective pharmacologic treatments for IBS-D are limited and include antispasmodics, antidepressants, antidiarrheal agents and alosetron. Learn more about IBS in AGA's patient brochure. Funding for this study was provided by Furiex Pharmaceuticals.

About the AGA Institute The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization. http://www.gastro.org.

About Gastroenterology Gastroenterology, the official journal of the AGA Institute, is the most prominent scientific journal in the specialty and is in the top 1 percent of indexed medical journals internationally. The journal publishes clinical and basic science studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. The journal is abstracted and indexed in Biological Abstracts, Current Awareness in Biological Sciences, Chemical Abstracts, Current Contents, Excerpta Medica, Index Medicus, Nutrition Abstracts and Science Citation Index. For more information, visit http://www.gastrojournal.org.

Like AGA and Gastroenterology on Facebook. Join AGA on LinkedIn. Follow us on Twitter @AmerGastroAssn. Check out our videos on YouTube. END


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[Press-News.org] New IBS treatment shows potential in Phase 2 study