Oct. 26, 2009 (Business Wire) -- Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announces that the 2009 American College of Gastroenterology (ACG) Annual Scientific Meeting will be the venue for 13 presentations describing the investigation of the Company’s bacterial-related disease, inflammatory bowel disease and bowel cleansing product lines. ACG is being held in San Diego, CA October 23-28.

Rifaximin Has a Favorable Long-Term Safety Profile for Maintenance of Remission from Overt Hepatic Encephalopathy

Oral 54, Wed., Oct. 28, 8:30 – 10:15 a.m., Room: Ballroom 20 AB

In an oral presentation, Dr. Muhammad Y. Sheikh and colleagues will present the results of an open-label maintenance extension study from the pivotal Phase 3, multinational, randomized, double-blind, placebo-controlled study of 299 patients with a history of hepatic encephalopathy (HE). The results demonstrate the rates and spectrum of adverse events (AEs) were similar in rifaximin-treated patients compared with patients receiving placebo. Most patients in both treatment arms – rifaximin and placebo – received concomitant lactulose therapy. A total of 336 patients, comprised of the 299 patients who completed the six-month randomized, double-blind, placebo-controlled trial plus 37 new patients, were treated with rifaximin for up to 840 days. Of these, 257 patients were on rifaximin for equal to or greater than six months and 114 patients were on rifaximin for equal to or greater than one year. In the six-month randomized trial, the pattern of adverse events was similar between rifaximin and placebo groups, with adverse events experienced by 80 percent of patients in each group. Fewer patients in the rifaximin group than the placebo group experienced severe AEs (26% vs 31%), drug-related AEs (19% vs 21%), serious AEs (36% vs 40%) and AEs leading to discontinuation (21% vs 28%). The safety profile of rifaximin during long-term treatment was similar to that in the six-month randomized trial.

“The robust data emerging from these studies clearly demonstrate that rifaximin has a very promising long-term safety profile for maintenance of remission from overt hepatic encephalopathy,” said Muhammad Y. Sheikh M.D., Associate Professor of Clinical Medicine, University of California San Francisco (UCSF) and Chief of Gastroenterology at UCSF Fresno. “With the previous data demonstrating rifaximin’s durable efficacy in the maintenance of remission of HE, these results continue to support rifaximin’s potential role in the long term management of this disabling complication of cirrhosis. We believe the availability of rifaximin has the potential to bring a paradigm shift in the management of HE. We have waited for such a pharmacologic change for more than 30 years. Today’s news marks another positive milestone for rifaximin and patients suffering from this serious condition.”

Long-Term Maintenance with Mesalamine Granules (1.5 g) in Patients Previously Treated with Corticosteroids is Associated with a Low Incidence of Ulcerative Colitis-Related Adverse Events

Poster 718 Mon, Oct. 26, 12:15 - 2:00 p.m.

Dr. Gary Lichtenstein and colleagues will present results describing the long-term (over 30 months) impact of once-daily mesalamine granules (MG) (1.5 g) on patients in remission from ulcerative colitis (UC) who were treated with steroids prior to enrollment. Patients were enrolled in two Phase 3, randomized, double-blind, placebo-controlled trials (RCT) and treated for six months with once-daily dosing of 1.5 g granulated mesalamine and then rolled over into a 24-month open label extension trial (OLT). The results of this long-term trial demonstrate that the reduced risk of treatment emergent adverse events and UC-related symptoms demonstrated during the two RCT trials (six months) was sustained over the subsequent OLT (24 months). In the two RCT trials, more MG-treated patients than placebo-treated patients remained relapse-free for six months (79.4 % vs. 63.0%; p<0.001). This highly significant effect also was noted in a subpopulation of 158 patients treated with steroids prior to enrollment (77% vs. 55%; p<0.004). Seventy four MG-treated patients from the two RCT trials continued MG treatment into the 24-month open label extension trial. The low probability of recurrence of events and symptoms was sustained during the 24-month open label extension trial.

"Ulcerative colitis is a chronic disease that requires continuous management and it is critically important to provide patients with a treatment option that will offer long-term symptom relief," said study author Gary R. Lichtenstein, M.D., Director, Inflammatory Bowel Disease Program, Gastroenterology Division, Department of Medicine, University of Pennsylvania.