Medication was approved recently by the U.S. Food and Drug Administration
THURSDAY, Jan. 21, 2016 (HealthDay News) — Eluxadoline (Viberzi) for irritable bowel syndrome (IBS) with diarrhea seems to reduce symptoms for some patients for at least six months, according to research published in the Jan. 21 issue of the New England Journal of Medicine. Based on these findings, eluxadoline was approved recently by the U.S. Food and Drug Administration.
Anthony Lembo, M.D., an associate professor of medicine at Harvard Medical School in Boston, and colleagues randomly assigned 2,427 adults with IBS with diarrhea to one of two doses of eluxadoline or a placebo. In one trial, patients took eluxadoline twice a day for 26 weeks, and in the other trial they took the drug for 52 weeks.
The researchers found that by the 12th week of the trials, between 25 and 30 percent of patients taking the highest dose of the drug (100 mg twice daily) saw improvement in their symptoms, compared with 16 to 17 percent of those taking the placebo. These results remained similar when assessed again at 26 weeks. The most common side effects of eluxadoline were nausea, constipation, and abdominal pain. The most serious side effect of eluxadoline was pancreatitis.
Eluxadoline shouldn’t be used in patients with a history of bile duct obstruction, severe liver impairment, or severe constipation, or in patients who drink more than three alcoholic beverages a day, according to the FDA.
The study was funded by Furiex Pharmaceuticals, an affiliate of Allergan, the manufacturer of eluxadoline.
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