In IBS3001, which had an additional 26 weeks of therapy to assess long-term safety, 27% of patients receiving 100 mg eluxadoline attained FDA composite responder endpoints, compared with 16.7% of placebo patients.
In IBS3002, which also included 4 weeks of placebo withdrawal, 31% receiving 100 mg eluxadoline were considered FDA composite responders, compared with 19.5% of placebo patients.
There was a slight increase in the number of adverse events, with 1.3% of all patients withdrawing from the trials because of constipation, Lembo said during his presentation.
“Eluxadoline is a first-in-class, oral, locally acting drug candidate for IBS-D, with a novel mechanism,” Lembo said. “Efficacy was demonstrated in two large phase 3 studies for which the FDA and EMA endpoints were assessed. There were significant improvements in primary endpoints, simultaneous improvements in both pain and diarrhea, seen within the first few days of therapy and throughout the 26 weeks of treatment.”
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Lembo A. #929d. Presented at: Digestive Disease Week 2014; May 3-6; Chicago.
CHICAGO — Patients with diarrhea-predominant irritable bowel syndrome treated with eluxadoline experienced greater rates of relief, compared with patients who received placebo, a researcher said during a late-breaking presentation at Digestive Disease Week.
In two randomized, double blind phase 3 clinical trials (IBS3001 and IBS3002), Anthony J. Lembo, MD, gastroenterologist at Beth Israel Deaconess Medical Center, Boston, and Harvard Medical School, and colleagues studied 2,474 patients with diarrhea-predominant irritable bowel syndrome (IBS-D). Patients were assigned 75 mg eluxadoline (n=807), 100 mg eluxadoline (n=859) or placebo (n=808) twice daily for 26 weeks.
Based on results from both trials, patients who received eluxadoline had higher responder rates for FDA (at 12 weeks) and European Medicines Agency (EMA; at 26 weeks) primary and secondary endpoints, including improvements in stool consistency and pain, than placebo patients. Patients in the 100-mg eluxadoline group had the greatest relief of IBS symptoms.