FDA Approves Two Drugs For Irritable Bowel Syndrome With Diarrhea

The health regulators, the U.S. Food and Drug Administration, or FDA, has given its approval to two drugs as the treatment for irritable bowel syndrome with diarrhea. The two drugs, Viberzi (eluxadoline) and Xifaxan (rifaximin), are manufactured by two different companies, Viberzi by Patheon Pharmaceuticals, Inc., Cincinnati, Ohio while Xifaxan is by Salix Pharmaceuticals, Inc., in Raleigh, North Carolina.

Irritable bowel syndrome, or IBS, is a type of disorder which affects the large intestine, causing symptoms like abdominal pain, cramps, bloating, constipation, gas and diarrhea, loose watery stools with frequent urge to rush to the toilet. According to Julie Beitz, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research, “For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder. The approval of two new therapies underscores the FDA’s commitment to providing additional treatment options for IBS patients and their doctors.”

Viberzi, can be taken orally two time a day, along with food. It contains a new active ingredient which has the capability to activate the receptors in the nervous system and reduces the contractions in the bowel. The drug can only be prescribed to adults suffering from IBS-D. The other drug, Xifaxan, can be prescribed for patients with IBS-D, demonstrating symptoms of abdominal pain and diarrhea .It can be taken orally three times a day for 14 days. Xifaxan is a rifampin derivative, an antibiotic previously approved to treat the travellers’ diarrhea caused by the gram-negative bacteria, E. coli. It can also be administered in adult patients with risk of hepatic encephalopathy that causes changes in brain function due to inability of the liver to flush out the toxins from the blood leading to their accumulation in brain.

A clinical trial, two double-blind, placebo-controlled was conducted in 2,425 patients who were randomly assigned to receive Viberzi or placebo to undermine the safety and efficacy of Viberzi for treatment of IBS-D. Results of the trial demonstrated that Viberzi over 26 weeks of treatment can effectively reduce abdominal pain as well as improve stool consistency simultaneously than placebo. The safety and effectiveness of Xifaxan was confirmed through three double-blind, placebo-controlled trials where participants showed improvement in symptoms such as abdominal pain and stool consistency.

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