22.05.2006 15:00:00
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Salix Pharmaceuticals Reports Digestive Disease Week 2006 Update; Monday, May 22 - Two XIFAXAN(R) Posters
Travelers' Diarrhea
Herbert L. DuPont, M.D., School of Public Health, University ofTexas-Houston and School of Medicine, University of Texas-Houston,Houston, TX, et al. compared the efficacy of the combination of theantibiotic rifaximin and the antimotility agent loperamide with thatof each agent administered alone. A total of 319 U.S. subjects,studying in Mexico, with acute diarrhea were randomized in adouble-blind study to receive one of three drug regimens: (R)rifaximin 200 mg TID; (L) loperamide four mg initially followed by twomg after each unformed stool; or (R/L) both drugs in the same dosageschedule for three days. Subjects completed a diary each day for fivedays. Over the five-day period, the median time from first dose ofdrug until passage of last unformed stool (TLUS) was shorter for bothrifaximin-containing regimens: R=23 hours, R/L=19.5 hours and L=41.5hours (p=0.01). The incidence of treatment failure was lower with therifaximin-containing regimens: R=7.5%, R/L=6.5% and L=16.3% (p=0.032).The median/mean numbers of unformed stools passed for the duration ofillness were lower with R/L 2.5/3.99 than with either treatment aloneR 4/6.23 and L 4/6.72 (p=0.002/0.004). In the first 10 hours afterdosing, results for TLUS favored loperamide; however, after the first10 hours, results favored rifaximin-containing regimens. An initialloperamide response was also observed for median number of stoolsduring the first 24 hours: R=2, L=1, R/L=1 (p=0.002). A total of 48subjects had a TLUS of zero hours: R=10, L=15 and R/L=23 (p=0.049).The study author summarized that while the loperamide effect wastransient with a high rate of continuing diarrhea, rifaximin treatmentresulted in clinical cure.
Hepatic Encephalopathy
Melissa Palmer, M.D., Plainview, NY, investigated the efficacy andtolerability of rifaximin for the treatment of stage 1 hepaticencephalopathy (HE) in patients with cirrhosis due to hepatitis Cvirus. A total of 37 outpatients were treated with rifaximin 400 mgTID for 14 days. Patients were assessed 24 hours prior to the start oftherapy and 14 days after completion of therapy for multipleparameters, including ability to perform mental tasks, asterixis and aquality of life composite score. Twenty-three patients were receivingpegylated interferon plus ribavirin for chronic HCV and 17 of thesepatients also were receiving a selective serotonin reuptake inhibitorfor mild IFN-induced depression. Type 2 diabetes mellitus was reportedin 12 patients. Rifaximin treatment lowered serum ammonia to normallevels in all patients, and overall, HE symptoms improved. Rifaximinwas well tolerated, with a low incidence of adverse events, and allpatients completed treatment.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, NorthCarolina, develops and markets prescription pharmaceutical productsfor the treatment of gastrointestinal diseases. Salix's strategy is toin-license late-stage or marketed proprietary therapeutic drugs,complete any required development and regulatory submission of theseproducts, and market them through the Company's 150-membergastroenterology specialty sales and marketing team.
XIFAXAN(R) (rifaximin) tablets 200 mg is indicated for thetreatment of patients (greater than or equal to 12 years of age) withtravelers' diarrhea caused by noninvasive strains of Escherichia coli.XIFAXAN should not be used in patients with diarrhea complicated byfever or blood in the stool or diarrhea due to pathogens other thanEscherichia coli. XIFAXAN should be discontinued if diarrhea symptomsget worse or persist more than 24-48 hours and alternative antibiotictherapy should be considered. In clinical trials, XIFAXAN wasgenerally well tolerated. The most common side effects (vs. placebo)were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominalpain 7.2% (vs. 10.1 %) and rectal tenesmus 7.2% (vs. 8.8%).
Salix also markets COLAZAL(R) Capsules 750 mg, VISICOL(R) Tablets,OSMOPREP(TM) Tablets, AZASAN(R), Anusol-HC(R) Cream 2.5%, Anusol-HC(R)25 mg Suppository, Proctocort(R) Cream 1% and Proctocort(R)Suppositories. MOVIPREP(R) and granulated mesalamine are underdevelopment.
Salix trades on the Nasdaq National Market under the ticker symbol"SLXP".
For more information on Salix please call 919-862-1000 or visitwww.salix.com. Information on the web site is not incorporated inSalix's SEC filings.
DDW is the largest international gathering of physicians,researchers and academics in the fields of gastroenterology,hepatology, endoscopy and gastrointestinal surgery. Jointly sponsoredby the American Association for the Study of Liver Diseases, theAmerican Gastroenterological Association, the American Society forGastrointestinal Endoscopy and the Society for Surgery of theAlimentary Tract, DDW takes place May 20-25, 2006, at the Los AngelesConvention Center. The meeting showcases approximately 5,000 abstractsand hundreds of lectures on the latest advances in GI research,medicine and technology. For more information, visit www.ddw.org.
Please Note: This press release contains forward-lookingstatements regarding future events. These statements are justpredictions and are subject to risks and uncertainties that couldcause the actual events or results to differ materially. These risksand uncertainties include risks of regulatory review and clinicaltrials, intellectual property risks, rapid growth and the need toacquire additional products. The reader is referred to the documentsthat the Company files from time to time with the Securities andExchange Commission.
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