Eluxadoline (Viberzi, Allergan), a new oral agent with mixed opioid effects, has met fairly stringent criteria for treatment response in men and women with irritable bowel syndrome (IBS) with predominant diarrhea, according to two phase 3 clinical trials published in the January 21 issue of the New England Journal of Medicine (read it here).
“Our primary outcome measure required simultaneous improvement in the daily scores for the worst abdominal pain and stool consistency on the same day for at least 50% of the days assessed. Patients who received eluxadoline reported a decrease in stool frequency and in urgency, which are two of the most bothersome symptoms of IBS with diarrhea.”
The investigators randomly assigned 2427 adults with IBS and diarrhea to eluxadoline at a dose of 75 or 100 mg or placebo, twice a day, for 26 weeks (the IBS-3002 trial), or to the same three treatment groups for 52 weeks (IBS-3001 trial). Safety data were collected for 26 weeks in the IBS-3002 trial and for 52 weeks in the IBS-3001 trial. Both doses of eluxadoline were significantly superior to placebo with respect to stool consistency, frequency, and urgency, although no significant reduction in episodes of incontinence was noted.”
The superior response to eluxadoline over placebo was seen within the first week of treatment, patients were told they could take no more than four doses over the course of 24 hours.”
Commentary:
Therapy for diarrhea predominant IBS is challenging and to have additional effective and safe therapy for this chronic condition is welcome. – Raymond W. Phillips, MD
Story Source:
The New England Journal of Medicine. “Eluxadoline for Irritable Bowel Syndrome with Diarrhea.” February 2016.