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Irritable Bowel Drugs Originally Developed by NC Firms Win FDA Nod

Xconomy Raleigh-Durham — 

Irritable bowel syndrome symptoms range from abdominal pain to diarrhea, but for years, patients had no FDA-approved treatment to turn to for relief. That changes with the agency’s approval of two new drugs that were originally developed by North Carolina pharmaceutical companies.

The FDA today approved Actavis’s (NYSE: ACT) eluxadoline (Viberzi), as well as rifaxamin (Xifaxan), a drug from Valeant Pharmaceuticals (NYSE: VRX). Both drugs were approved for the treatment of irritable bowel syndrome with diarrhea in adults. Eluxadoline was originally developed by Morrisville, NC, company Furiex Pharmaceuticals, which was acquired in 2014 by Forest Laboratories for $1.1 billion. Forest was later acquired by Actavis.

Rifaxamin was the top product for Salix Pharmaceuticals, the Raleigh, NC, gastrointestinal drugs company that was briefly the subject of a bidding war between Endo (NASDAQ: ENDP) and Valeant. Valeant won the acquisition battle in March after improving its offer to more than $11 billion. Valeant closed the acquisition on April 1.

At the time of the acquisition, rifaxamin had already notched FDA approval as a treatment for traveler’s diarrhea and, separately, for hepatic encephalopathy, a condition in which a damaged liver can’t remove toxins that can then lead to brain damage.

Rifaxamin accounted for more than $405 million in 2014 revenue, according to Salix’s restated financial results.

Both the American College of Gastroenterology and the FDA cite studies estimating that 10 to 15 percent of American adults suffer from irritable bowel syndrome. The two new drugs treating the condition work in different ways. The Actavis drug, a twice-daily pill, activates receptors in the nervous system that can reduce bowel contractions.

Rifaxamin for IBS is a pill taken three times a day for 14 days. Its exact mechanism of action in treating IBS is not known but, as an antibiotic, it is thought to have an effect on gut bacteria. In approving the two new irritable bowel syndrome drugs, the FDA acknowledged that patients would benefit from having multiple treatment options.

“For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder,” Julie Beitz, director of the FDA’s Office of Drug Evaluation said in a prepared statement.
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