Valeant (VRX) Stock | FDA Approval of Xifaxan


Valeant Pharmaceuticals Intl. (NYSE: VRX

Shares of Valeant Pharmaceuticals International, Inc. rose 1.5% on Wednesday to a new 52 week high of $239.12. The U.S. Food and Drug Administration approved the drug Xifaxan today to treat irritable bowel syndrome with diarrhea (IBS-D) in adult men and women. IBS affects roughly 10 to 15% of adults in the United States. Close to 35 million adults may suffer the symptoms of IBS and other diarrhea related symptoms based on estimates from the company.

Notable Comments On VRX

“As a gastroenterologist who helps patients navigate the symptoms of IBS-D, I see the need for treatments that directly address those most bothersome, such as diarrhea and abdominal pain” said Dr. Mark Pimentel, director of the Gastrointestinal Motility Program and Laboratory at Cedars-Sinai in Los Angeles. “Today’s approval gives a new option to these patients and providers.”

Valeant Aquires Salix

Valeant acquired Xifaxan when it purchased North Carolina based Salix Pharmaceuticals for $11 billon last month. Valeant announced plans to lay off 258 Salix workers the day after the acquisition of Salix was finalized. Senior executives with the company were offered $78 million in golden parachutes after the deal was closed. Such are the breaks when dealing for a company with a highlyy anticipated FDA indication. Valeant was in a bidding war with Endo International (NASDAQ: ENDP) for Salix in March of this year. Xifaxan is the top selling product for Salix, accounting for $405 million in sales in 2014. Now with the new indication from the FDA, the sales of the drug are sure to surge higher. Before the new indication, Xifaxan was previously approved for diarrhea caused by E. coli and for reducing the risk in adult patients of recurring overt hepatic encephalopathy. This is a condition where the liver is unable to remove toxins from the bloodstream. The FDA also approved the drug Viberzi for IBS-D as well today. Viberzi is manufactured by Pantheon Pharmaceuticals based in Cincinnati, Ohio.  

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About IBS

Irritable bowel syndrome (IBS) is a common disorder that affects the large intestine (colon). Irritable bowel syndrome commonly causes cramping, abdominal pain, bloating, gas, diarrhea and constipation. IBS is a chronic condition that you will need to manage long term.

Even though signs and symptoms are uncomfortable, IBS — unlike ulcerative colitis and Crohn’s disease, which are forms of inflammatory bowel disease — doesn’t cause changes in bowel tissue or increase your risk of colorectal cancer.