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Reged: 12/09/02
Posts: 7677
Loc: Seattle, WA
Mixed Opioid Agent Adds to Growing List of Therapies for IBS-D
      01/27/16 02:48 PM

Medscape Medical News

Mixed Opioid Agent Adds to Growing List of Therapies for IBS-D

Pam Harrison
January 27, 2016

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.

"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; this end point is currently one of those recommended by the regulatory agencies in the United States and Europe to show treatment effect in trials involving patients with IBS and diarrhea," Anthony Lembo, MD, from Harvard Medical School, Boston, Massachusetts, and colleagues write.

"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. Loperamide was allowed as needed during the double-blind study interval, but patients were told they could take no more than four doses over the course of 24 hours.

From weeks 1 through 12, the proportion of patients receiving either dose of eluxadoline in the IBS-3001 trial who achieved a US Food and Drug Administration (FDA) end-point response was significantly greater, at 23.9% among those receiving the 75-mg dose and 25.1% for those receiving the 100-mg dose, compared with 17.1% of placebo controls (P = .01 and P = .004, respectively).

From weeks 1 through 26, the proportion of patients in the IBS-3001 trial receiving active treatment who reached the European Medicines Agency end-point response was higher in both dosing groups, at 23.4% in the 75-mg group and 29.3% for the 100-mg group compared with 19.0% for control patients receiving placebo (P = .11 and P < .0001, respectively).

In the IBS-3002 trial, 30.4% of those in the 75-mg group and 32.7% in the 100-mg group similarly reached a European Medicines Agency end-point response compared with 20.2% of placebo controls (P = .001 and P < .001, respectively).

"In addition, 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 investigators observe.

The superior response to eluxadoline over placebo was seen within the first week of treatment, they add.

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Subject Posted by Posted on
* Pharmaceutical HeatherAdministrator 07/14/03 01:50 PM
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. * Mixed Opioid Agent Adds to Growing List of Therapies for IBS-D HeatherAdministrator   01/27/16 02:48 PM
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