UPDATE 1-FDA approves Actavis, Valeant drugs for irritable bowel syndrome

Wed May 27, 2015 5:42pm EDT
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(Adds background, details from FDA, paragraphs 5-11)

By Toni Clarke

WASHINGTON May 27 (Reuters) - U.S. health regulators approved new irritable bowel syndrome drugs from Actavis Plc and Valeant Pharmaceuticals International Inc on Wednesday, validating big investments both companies made to acquire the products.

The Food and Drug Administration approved eluxadoline, to be sold under the brand name Viberzi, which Actavis obtained with its $1.1 billion acquisition last year of Furiex Pharmaceuticals.

The agency also approved Valeant's Xifaxan, also known as rifaximin, which the company acquired with its $11 billion purchase earlier this year of Salix Pharmaceuticals Ltd.

Both drugs are designed to treat diarrhea-predominant irritable bowel syndrome (IBS-D), a condition that affects about 28 million people in the United States and Europe and can cause abdominal pain, bloating and diarrhea.

Analysts expect Viberzi to generate U.S. sales of about $450 million by 2020 according to Thomson Reuters data. They expect Xifaxan sales for IBS-D to top $1 billion.

The two drugs work differently. Xifaxan is an antibiotic that was approved in 2004 to treat traveler's diarrhea. It was approved in 2010 to reduce the risk of hepatic encephalopathy, or brain abnormalities associated with liver disorders.

Viberzi is known as a combination mu opioid receptor agonist and delta opioid receptor antagonist. It is designed to treat IBS-D while reducing the risk of constipation that can occur with other mu opioid receptor agonists, such as the anti-diarrhea drug Imodium.   Continued...