The US Food and Drug Association (FDA) granted approval for eluxadoline (Viberzi) and rifaximin (Xifaxan), to treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.
The US Food and Drug Association (FDA) granted approval for eluxadoline (Viberzi) and rifaximin (Xifaxan), to treat irritable bowel syndrome with diarrhea (IBS-D in adult men and women.
Viberzi and Xifaxan, manufactured and marketed by Patheon Pharmaceuticals Inc. and Salix Pharmaceuticals Inc., respectively, were evaluated for safety and efficacy in two independent studies.
An observational study of 2,425 patients administered Viberzi or placebo indicated that the treatment was more effective than placebo in diminishing abdominal pain and improving stool consistency over a treatment period of 26 weeks.
The 3 trials for Xifaxan involved a total of 1,894 individuals randomly assigned to take either Xifaxan or placebo. The team of researchers found patients who were treated with Xifaxan saw clear improvements in both abdominal pain and stool consistency than those who were simply administered the placebo.
The most commonly reported adverse events with Viberzi were abdominal pain, constipation, and nausea. Xifaxan was reported to potential cause nausea and an increase in alanine aminotransferase.
Experts note Viberzi can be taken twice daily with food, and Xifaxan can be taken orally 3 times a day for 2 weeks to treat both abdominal pain and diarrhea.
However, if the patients appear to experience symptom recurrence, they can safely retake Xifaxan up to 2 times during a 2-week period.
Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research, commented in a press release, “For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder. The approval of 2 new therapies underscores the FDA’s commitment to providing additional treatment options for IBS patients and their doctors.”