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July 7, 2015
Two new medications manufactured by separate companies have gained FDA approval for treating irritable bowel syndrome with diarrhea (IBS-D) in adults.
One of the drugs, eluxadoline, which is marketed as Viberzi, activates receptors in the nervous system that can lessen bowel contractions. In 2 randomized, double-blind, placebo-controlled trials involving 2425 patients, eluxadoline was more effective than placebo in simultaneously reducing abdominal pain and improving stool consistency over 26 weeks of treatment. The most common adverse effects associated were constipation, nausea, and abdominal pain (http://1.usa.gov/1dAfFBH).
The other drug, rifaximin, is an antibiotic derived from rifampin, which previously was approved to treat travelers’ diarrhea caused by Escherichia coli infection. Marketed as Xifaxan, rifaximin was shown safe and more effective than placebo in 2 randomized, double-blind trials involving 1258 patients treated for 14 days followed by a 10-week treatment-free period. In a trial with 636 patients whose IBS-D symptoms recurred, those treated with 2 additional 14-day courses separated by 10 weeks had better symptom improvement than participants who received a placebo. Xifaxan’s most common adverse effects included nausea and an increase in alanine aminotransferase, which may indicate liver injury.