"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.
As many as 35 million adult Americans may experience IBS, and 40% of people with IBS suffer from diarrhea-prominent symptoms that include urgency, loose, watery stools and abdominal pain.i,ii,iii Although millions suffer from the condition, current treatments for IBS-D are limited to products aimed at relieving individual symptoms (e.g., antispasmodics, anti-diarrheal agents, bulking agents, anti-flatulence agents) and fail to address the syndrome complex.
"The Xifaxan 550 mg approval gives patients access to a treatment that may alleviate their symptoms," said Dr. Costas H. Kefalas, president and member of the Board of Directors of the
The
"We are thrilled to offer patients this new option to manage their IBS-D symptoms," said
Xifaxan 550 mg offers a safety and tolerability profile comparable to placebo when used as directed.
Xifaxan is also
About IBS
Irritable bowel syndrome (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.
About Gut Microbiota
The significant influence of the gut microbiota on human physiology, functioning and health has brought about a paradigm shift in understanding the pathophysiology of many human diseases, including IBS. Recent findings suggest that some IBS patients may have an alteration in their gastrointestinal flora.
About XIFAXAN 550 mg
Indication:
XIFAXAN (rifaximin) 550 mg tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
XIFAXAN (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
Important Safety Information about XIFAXAN 550 mg
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XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
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Clostridium difficile-associated diarrhea (CDAD) has been reported with use of antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
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Use with caution in patients with severe (Child-Pugh Class C) hepatic impairment.
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Exercise caution when administrating XIFAXAN concomitantly with a P-glycoprotein (P-gp) inhibitor such as cyclosporine. Concomitant administration of drugs that are P-gp inhibitors can substantially increase the systemic exposure to XIFAXAN. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase the systemic exposure to XIFAXAN.
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XIFAXAN may cause fetal harm. Discontinue in nursing mothers after taking into account the importance of the drug to the mother.
- The most common adverse reactions for XIFAXAN are peripheral edema, nausea, elevated liver enzymes (ALT), dizziness, fatigue, and ascites.
About Valeant
About Salix
Contact Information: |
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Valeant Investors: |
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Laurie W. Little |
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949-461-6002 |
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Valeant Financial Media Contacts: |
Salix Media Contacts: |
Sard Verbinnen & Co |
Edelman |
Renée Soto/ Meghan Gavigan/Jared Levy |
Sarah Hamilton |
212-687-8080 |
404-460-9675 |
i Saito YA, Schoenfeld P, Lock GR 3rd. The epidemiology of irritable bowel syndrome in
ii Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta analysis. Clin Gastroenterol Hepatol. 2012;10:712-721
iii Pimentel, MP et al. Rifaximin Therapy for Patients with Irritable Bowel Syndrome without Constipation. The New England Journal of Medicine. 200;364:22-32