New Viberzi Data Show Significant Improvements in IBS-D Symptoms
Allergan announced the publication of the positive results of two Phase 3 trials of Viberzi (eluxadoline) for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Findings are published in the January 21st issue of The New England Journal of Medicine (NEJM).
Studies 1 and 2 are randomized, multicenter, multinational, double-blind, placebo-controlled Phase 3 trials evaluating Viberzi 75mg, Viberzi 100mg, and placebo twice daily in a total of 2425 patients with IBS-D. Both studies included 26-week treatment periods, with Study 1 continuing for additional 26 weeks for a long-term safety study and Study 2 continuing for additional 4 weeks for a single-blinded, placebo-withdrawal period. Loperamide was the only medication allowed as rescue treatment for acute diarrhea. No narcotic or opioid-containing agents were allowed.
Trial results showed that significantly greater patients treated with Viberzi experienced improvements in diarrhea and abdominal pain vs. placebo. Efficacy, defined as simultaneous reductions in the daily worst abdominal pain score by >30% as compared to the baseline weekly average and a reduction in the Bristol Stool Scale (BSS) to <5, on at least 50% of the days within a 12-week treatment interval, was achieved and sustained by Viberzi in these trials.
Based on positive results from these trials, the Food and Drug Administration (FDA) approved Viberzi 75mg and 100mg as a twice-daily, oral treatment for IBS-D.
Viberzi is a CIV mu-opioid receptor agonist with a mixed opioid receptor activity at the delta (antagonist) and kappa (agonist) receptors that acts locally in the gut.
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