The U.S. Food and Drug Administration (FDA) has approve the medicine Viberzi® (eluxadoline) for the treatment of patients with irritable bowel syndrome (IBS)—specifically, for patients with IBS diarrhea (IBS-D). Viberzi has proven effective in two Phase III clinical trials.
Irritable bowel syndrome is a disorder that affects the large intestine, or colon. Its symptoms include cramping, abdominal pain, bloating, constipation, and diarrhea. IBS is common, affecting up to 20 percent—one in five—of adults in the United States. More women suffer from IBS than men. There is currently no known cause of IBS, but, according to research, it’s probably the result of sensitivity of the large intestine to certain foods and stress. Effective treatments for IBS are very much needed.
Viberzi is an oral medicine that works by activating receptors in the nervous system that can lessen the bowel contractions associated with diarrhea and pain of IBS.
Two Phase III trials were used to determine if Viberzi could help manage symptoms of IBS-D. In both studies, results were compared between patients given Viberzi or placebo. Patients who were treated with Viberzi had significant improvement in abdominal pain and diarrhea compared with those on placebo.
The most common side effects associated with Viberzi were constipation and nausea. These side effects were not severe, however, and affected only a small proportion of patients.
According to drug maker Actavis, the FDA approval of Viberzi is an important step in making evidence-based treatment available to patients with IBS-D.
Reference: Actavis Receives FDA Approval for Viberzi® (eluxadoline) for the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D) in Adults [press release]. Actavis website. Available at: http://www.actavis.com/NEWS/News/Thomson-Reuters/Actavis-Receives-FDA-Approval-for-VIBERZI-eluxadol. Accessed May 26, 2015.