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.”
Funding for this study was provided by Furiex Pharmaceuticals.
Leonard S. Dovee, Anthony Lembo, Charles W. Randall, Ronald Fogel, David Andrae, J. Michael Davenport, Gail Mcintyre, June S. Almenoff, Paul S. Covington. Gastroenterology,Volume 145, Issue 2 , Pages 329-338.e1, August 2013, doi:10.1053/j.gastro.2013.04.006