NAPSR News: FDA Approves Xifaxan from Valeant to treat IBS-D

WASHINGTON - May 28, 2015 - PRLog -- Valeant Pharmaceutical’s wholly owned subsidiary, Salix Pharmaceuticals, Inc received approval from the U.S. Food and Drug Administration (FDA) for Xifaxan® 550 mg to treat IBS-D (Irritable Bowel Syndrome with Diarrhea) in adults. The FDA’s decision stemmed from data collected in three phase 3 studies, TARGET 1, TARGET 2 and TARGET 3. Xifaxan 550 mg demonstrated satisfactory efficacy and safety in over 3,000 patients after a two-week course of treatment versus placebo.

"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 theGastrointestinal Motility Program and Laboratory at Cedars-Sinai in Los Angeles. "Today's approval gives a new option to these patients and providers."

IBS is a chronic condition affecting approximately 35 million adult Americans and 40% of  IBS sufferers experience diarrhea-prominent symptoms that include urgency, loose, watery stools and abdominal pain. The treatment options available for IBS-D are restricted only to products that alleviate the symptoms and do not address the syndrome complex.  "We are thrilled to offer patients this new option to manage their IBS-D symptoms," said Bill Forbes, PharmD, president, medical, R&D and chief development officer of Salix. "The FDA approval in IBS-D extends the reach of Xifaxan 550 mg beyond hepatic encephalopathy to a population greatly in need of a different treatment approach."

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