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FDA approves Salix and Actavis IBS drugs


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FDA approves Salix and Actavis IBS drugs

 

Date: 01/06/2015


Two new treatments for irritable bowel syndrome (IBS) have been approved by the US Food and Drug Administration.

Salix' Xifaxan and Actavis' Viberzi were given the green light to treat adults with IBS with diarrhoea (IBS-D).

Julie Beitz, director of the FDA’s Office of Drug Evaluation III, said: “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, which contains a new active ingredient, is taken orally twice daily with food and works by activating receptors in the nervous system that can lessen bowel contractions.

Its approval came on the back of two double-blind, placebo-controlled clinical trials involving nearly 2,500 patients that found patients receiving Viberzi was more effective in simultaneously reducing abdominal pain and improving stool consistency than placebo over 26 weeks of treatment.

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Source: Pharmatimes

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