Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the availability of Xifaxan® (rifaximin) 550 mg tablets (Xifaxan550) for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients 18 years of age or older. Those HE patients may now fill their Xifaxan 550 mg prescriptions in U.S. pharmacies and should speak with their doctors about this important treatment option. HE is a serious disorder caused by chronic liver failure resulting in neurologic impairments in cognition, mental status and motor function. Xifaxan 550 mg was approved by the U.S. Food and Drug Administration (FDA) on March 24, 2010 in a twice daily dose.

The availability of Xifaxan 550 mg occurs in tandem with the launch of Salix's Hepatic Encephalopathy Living Program ((H.E.L.P.) ), a first-of-its-kind patient and health care provider support program for overt HE patients 18 years of age or older. The program provides those HE patients with educational materials, co-pay assistance, treatment adherence support and a 24-hour toll-free hotline. Upon registration, patients will receive a co-pay assistance card, which can offer up to $100 in reimbursement for each prescription for one year.

"The availability of Xifaxan 550 mg is an important milestone for patients suffering from overt hepatic encephalopathy," said Arun Sanyal, MD, Chairman, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University Medical Center. "This drug is supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, demonstrating not only a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence, but also a risk reduction of HE-related hospitalization."

HE frequently occurs in patients with cirrhosis, or end-stage liver disease, and encompasses a wide spectrum of often reversible neuropsychiatric abnormalities, including disruption in sleep patterns, changes in personality and intellectual capacity and coma. There are reported to be approximately 200,000 patients in the United States who suffer from episodic overt HE.i,ii,iii

"HE is a growing health concern that, historically, has had limited treatment options. There is an urgent need for healthcare providers, patients and their families to understand the threat posed by overt HE and to seek information about how to recognize its symptoms and obtain treatment," said Bill Forbes, PharmD, Executive Vice President, Research and Development and Chief Development Officer, Salix Pharmaceuticals. "Today we are proud to offer the first new treatment option in 30 years, along with a program to help educate and assist those at risk for overt HE recurrence."

For more information on Xifaxan 550 mg, please visit Xifaxan550. For more information regarding H.E.L.P., please visit HELPenroll.

XIFAXAN® (rifaximin) 550 mg tablets

Important Safety Information

XIFAXAN 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥ 18 years of age. In the trials of XIFAXAN for HE, 91 percent of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores > 25, and only 8.6 percent of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).


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.

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C. difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

The most common adverse reactions occurring in >8 percent of patients in the clinical study were edema peripheral (15 percent), nausea (14 percent), dizziness (13 percent), fatigue (12 percent), ascites (11 percent), muscle spasms (9 percent), pruritus (9 percent), and abdominal pain (9 percent).

About XIFAXAN® (rifaximin)

Rifaximin is a gut-selective antibiotic with negligible systemic absorption and broad-spectrum activity in vitro against both gram-positive and gram-negative pathogens. Rifaximin has a similar tolerability profile to that of placebo.

Rifaximin tablets 200 mg, which Salix markets in the United States under the trade name XIFAXAN® (rifaximin) tablets 200 mg, currently is approved for the treatment of patients, 12 years of age or older, with travelers' diarrhea (TD) caused by non-invasive strains of Escherichia coli. XIFAXAN (rifaximin) should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. XIFAXAN (rifaximin) should be discontinued if diarrhea symptoms get worse or persist more than 24��"48 hours, and alternative antibiotic therapy should be considered. In clinical trials, XIFAXAN (rifaximin) was generally well-tolerated. The most common side effects (vs. placebo) were flatulence 11.3 percent (versus 19.7 percent), headache 9.7 percent (versus 9.2 percent), abdominal pain 7.2 percent (versus 10.1 percent) and rectal tenesmus 7.2 percent (versus 8.8 percent).

Rifaximin has been used in Italy for 24 years and is approved in 33 countries. Salix acquired rights to market rifaximin in North America from Alfa Wassermann S.p.A. in Bologna, Italy. Alfa Wassermann markets rifaximin in Italy under the trade name Normix®.

About Hepatic Encephalopathy

Hepatic encephalopathy (HE) is a disorder caused by chronic liver failure resulting in cognitive, psychiatric and motor impairments. The condition encompasses a wide spectrum of often reversible neuropsychiatric abnormalities caused by the inability of the liver to remove toxic products in the gut from most notably ammonia-producing bacteria. When toxins reach the central nervous system, this condition can result in symptoms ranging in severity from mild cerebral function deficits to coma. The disorder is characterized by disruption in sleep patterns, changes in personality and intellectual capacity, high blood ammonia levels, altered neuromuscular activity and electroencephalogram (EEG) abnormalities.

i Dufour. In: Everhart, ed. Digestive Diseases in the United States: Epidemiology and Impact. 1994: 613-646. NIH publication No. 94-1447.

ii Guevara et al. Am J Gastroenterol. 2009;104:1382-1389.

iii eMedicine Health. Cirrhosis. Available here. Accessed: March 22, 2010.

Source
Salix Pharmaceuticals, Ltd.

View drug information on Xifaxan.