Allergan (NYSE: AGN) on Thursday said The New England Journal of Medicine (NEJM) has published positive results from late stage trials of its Viberzi C IV (eluxadoline) to treat irritable bowel syndrome with diarrhea (IBS-D).
The company said two Phase III trials showed significantly more patients treated with Viberzi experienced improvements in diarrhea and abdominal pain, as compared with placebo. IBS-D is a functional bowel disorder commonly characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 15 million patients in the USA.
David Nicholson, president and executive vice president of global R&D at Allergan, said: “These significant Phase III results highlight the efficacy of Viberzi, demonstrating an exciting new treatment option that provides improvements for two of the most common symptoms of IBS-D, which patients have struggled to address. With so many Americans forced to deal with limited treatment options, Viberzi is an effective first-in-line therapy that is positioned to address a major unmet need.”
A total of 1,280 patients in Study 1 and 1,145 patients in Study 2 received treatment with Viberzi 75mg, Viberzi 100mg or placebo twice daily. Overall, the patients were a mean age of 45 years.
Based on efficacy of Viberzi 75mg and 100mg at 12 weeks of treatment, Viberzi was approved by the US Food and Drug Administration as a twice-daily, oral treatment indicated for use in adults suffering from IBS-D. Viberzi has mixed opioid receptor activity – it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist that acts locally in the gut.