Eluxadoline Reports IBS-D Symptom Treatment Efficacy and Safety
The additional results of 2 Phase III studies (IBS-3001 and IBS-3002) of the Allergan drug analyzed its efficacy in nearly 2,500 IBS-D patients — of whom 36% had used loperamide within a year of study randomization.
Additional results of Viberzi (Eluxadoline) for treating symptoms of irritable bowel syndrome with diarrhea (IBS-D), abdominal pain, and diarrhea have shown its efficacy and safety for patients who reported inadequate response to prior loperamide use.
Eluxadoline — a twice daily, oral medication used to treat adults with IBS-D — is a mu- and kappa-opioid receptor agonist and a delta-opioid receptor antagonist. It acts locally in the gut and, according to nonclinical studies, is believed to decrease visceral hypersensitivity and control gastrointestinal activity.
Versus placebo, a significantly greater portion of patients with prior loperamide use reported composite response when treated with 2 different doses of eluxadoline over 1-12 weeks (100 mg: 27%; 75 mg: 26.3%; placebo: 12.7%). Patients reported adverse effects such as nausea, abdominal pain, constipation, and headaches.
IBS-D currently affects about 16 million people, studies lead author Brian E. Lacy, MD, PhD, Division of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, said. Despite frequently-used medications, many patients still experience the syndrome's debilitating symptoms with "little to no relief."
"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," Lacy said.
The 2 study analyses also demonstrated efficacy and safety in patients with loperamide rescue medication use compared to the overall population during the 2 studies.
"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," David Nicholson, PhD, Chief Research & Development Officer of Allergan, said.
A press release regarding the studies was made available.