Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the availability of Xifaxan® (rifaximin) 550 mg tablets (www.Xifaxan550.com) 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.
“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.”
The availability of Xifaxan 550 mg occurs in tandem with the launch of Salix's Hepatic Encephalopathy Living Program (H.E.L.P.) (www.HELPenroll.com), 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.
"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."
SOURCE Salix Pharmaceuticals, Ltd.