Viberzi proven safe and effective in patients who reported inadequate response to prior loperamide use.

Allergan has announced additional results of a prespecified prospective pooled subgroup analysis from the two Phase III studies (IBS-3001 and IBS-3002), which evaluated the efficacy and safety of Viberzi in nearly 2,500 IBS-D patients, of whom 36% reported use of loperamide in the 12 months prior to study randomization. These data demonstrate Viberzi (eluxadoline) safely and effectively treats the IBS-D symptoms of abdominal pain and diarrhea irrespective of prior use of loperamide. These analyses also demonstrated efficacy and safety in patients with loperamide rescue medication use compared to the overall population during the two studies.

"Irritable bowel syndrome with diarrhea is a health concern that affects approximately 16 million people, and despite the use of over-the-counter medications, many patients experience debilitating symptoms associated with the syndrome and often cycle through several options with little to no relief," said lead author Brian E. Lacy, MD, PhD, Division of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center. "These results further support the use of eluxadoline to provide significant and effective relief from abdominal pain and diarrhea, two of the most common symptoms affecting those suffering with IBS-D, regardless of prior treatment experience."

Among patients who reported prior loperamide use with inadequate symptom control, a significantly greater proportion of patients treated with eluxadoline were composite responders over weeks 1-12 compared with those treated with placebo (eluxadoline 100 mg: 27.0% and 75 mg: 26.3% versus placebo 12.7%). The most commonly reported adverse events are consistent with the known safety profile of eluxadoline, which were nausea, abdominal pain, constipation and headache.

"These results continue to build on the robust clinical profile that has already been established, and further underscores Viberzi as a safe and effective treatment option for patients suffering from inadequate symptom control associated with a commonly used treatment for IBS-D," said David Nicholson, Chief Research & Development Officer, Allergan.