Valeant Pharmaceuticals International Inc. (VRX, VRX.TO) announced Wednesday that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration or FDA for Xifaxan 550 mg for the treatment of Irritable Bowel Syndrome with Diarrhea or IBS-D in adults.
The FDA approval of Xifaxan 550 mg is based on data from three phase 3 studies, TARGET 1, TARGET 2 and TARGET 3. Xifaxan 550 mg was studied in over 3,000 patients and demonstrated the efficacy and safety of repeat treatment following completion of a two-week course of treatment. A full course of Xifaxan 550 mg for IBS-D is available in a convenient 2 week pack of 42 pills.
Xifaxan is also FDA-approved to manage hepatic encephalopathy (550 mg). Recommended dosing for Xifaxan 550 mg for IBS-D is one 550 mg tablet three times a day for 14 days. Patients can take up to two additional courses if IBS-D symptoms recur in the future. Xifaxan 550 mg is currently available to patients.
Irritable bowel syndrome or IBS is a chronic gastrointestinal disorder characterized by recurrent abdominal discomfort or pain that is accompanied by at least two of the following: relief by a bowel movement, change in frequency of stool, or change in consistency in stool.
IBS is thought to affect approximately 35 million Americans, is nearly twice as common in women as men, and is most commonly found in people under the age of 45. Forty percent of people with IBS suffer diarrhea-prominent symptoms.
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