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Salix Pharmaceuticals Reports Digestive Disease Week 2006 Update; Tuesday, May 23 - Two OSMOPREP(TM) and One XIFAXAN(R) Posters.


RALEIGH, N.C. -- Salix Pharmaceuticals, Ltd. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:SLXP) today announced results of two Company-sponsored trials of OSMOPREP(TM) and one investigator-initiated trial of XIFAXAN(R) (rifaximin) tablets 200 mg that were presented today at Digestive Disease Week(R) 2006.

OSMOPREP Versus VISICOL(R): Irrigation Requirements During Colonoscopy

David Kastenberg, M.D., Thomas Jefferson University It began as Jefferson Medical College in 1824. On July 1, 1969 the institution officially became Thomas Jefferson University.

The university is made up of three colleges:
  • Jefferson Medical College
  • Jefferson College of Graduate Studies
, Philadelphia, PA, reported on a multicenter, investigator-blinded study of 704 patients that compared the irrigation requirements during colonoscopy for our two different sodium phosphate tablet bowel cleansing agents: OSMOPREP, the recently approved microcrystalline cellulose (MCC)-free formulation; and VISICOL, a formulation containing 13% MCC. Patients were randomized to receive either 40 tablets of OSMOPREP, 32 tablets of OSMOPREP or 40 tablets of VISICOL. Patients took 20 tablets the evening prior, and the remainder the next morning 3-5 hours before colonoscopy. Overall colon cleansing was evaluated in terms of colonic content and need for suctioning. Irrigation requirements during colonoscopy were scored based on volume. Colon cleansing was comparable between the three groups with greater than or equal to 95% having Excellent/Good scores. Less irrigation was required for both OSMOPREP groups compared to VISICOL. Significantly fewer patients receiving 40 (21%) and 32 tablets (25%) of OSMOPREP required irrigation during colonoscopy compared with patients receiving VISICOL (44%) (p=0.0001). Mean irrigation scores were significantly lower for patients receiving OSMOPREP tablets compared to VISICOL (p=0.0001).

OSMOPREP Versus VISICOL: Comparison of Overall and Ascending Colon Cleansing Rate

Douglas Rex, M. D., Indiana University Medial Center, Indianapolis, IN, reported on a pooled efficacy analysis of Phase II and III randomized clinical trials that was conducted to evaluate the efficacy of OSMOPREP versus VISICOL. A total of 262 patients received 40 OSMOPREP tablets, 269 received 32 OSMOPREP tablets and 264 received 40 VISICOL tablets. Overall colon cleansing (OCC) and ascending colon cleansing (ACC) were assessed based upon colonic contents. Patients were considered responders if they achieved a rating of "Excellent" (greater than 90% of mucosa observed, mostly liquid colonic contents, minimal suctioning required) or "Good" (greater than 90% mucosa observed, mostly liquid stool, significant suctioning required) colon cleansing. The percentage of OCC responders reported was 97% for OSMOPREP 40 tablet patients, 96% for OSMOPREP 32 tablet patients and 94% VISICOL 40 tablet patients. The percentage of ACC responders was significantly higher for OSMOPREP compared to VISICOL with 96% of OSMOPREP 40 tablet and 94% of OSMOPREP 32 tablet patients responding compared with 88% VISICOL 40 tablet patients (p= 0.0006 and 0.0090 for 40 and 32 tablet patients, respectively.) The percentage of these responders rated as "Excellent" was 74% for OSMOPREP 40 tablets, and 76% for OSMOPREP 32 tablets, compared with 51% for VISICOL 40 tablets.

Irritable Bowel Syndrome irritable bowel syndrome (IBS), condition characterized by frequently alternating constipation and diarrhea in the absence of any disease process. It is usually accompanied by abdominal pain, especially in the lower left quadrant, bloating, and flatulence.  

James George, M. D., Mount Sinai Medical Center, New York, NY, et al. conducted an open-label pilot study to determine if higher doses of rifaximin would improve symptoms in patients with constipation-predominant IBS (IBS-C) who tested positive for bacterial overgrowth. A total of 14 patients with IBS-C were determined to have small intestinal bacterial overgrowth intestinal bacterial overgrowth Afferent loop syndrome, gastrojejunal loop obstruction, stagnant loop syndrome Infectious disease A condition characterized by excess growth of opportunistic bacteria, which occurs when normal gut flora is eradicated with antibiotics  (SIBO) based upon results of a lactulose lactulose /lac·tu·lose/ (lak´tu-los) a synthetic disaccharide used as a laxative and to enhance excretion or formation of ammonia in the treatment of hepatic encephalopathy.  breath test. These patients had a mean increase of 37 ppm in H2 over two hours after oral ingestion of 50 mg lactulose. Seven patients were treated with rifaximin 400 mg BID for 10 days and seven patients were treated with rifaximin 400 mg TID for 10 days. A total of 64% of patients (six of seven patients treated with 1200 mg/day (87%) and three of seven treated with 800 mg/day (43%)) had improvement in constipation and bloating bloating Vox populi A lay term for post-prandial abdominal fullness or swelling . Symptomatic improvement occurred within the first week of treatment in all patients. A total of six patients relapsed within two weeks of discontinuation of therapy and all of these improved with reinstitution to rifaximin. Eight patients remained in remission for at least four weeks after cessation of rifaximin. All patients tolerated rifaximin treatment without adverse events.

Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina For other uses of this name, see Raleigh.
Raleigh (IPA: /ˈrɑli/, ral-ee) is the capital of the State of North Carolina and the county seat of Wake County.
, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the Company's 150-member gastroenterology specialty sales and marketing team.

XIFAXAN(R) (rifaximin) tablets 200 mg is indicated for the treatment of patients (greater than or equal to 12 years of age) with travelers' diarrhea caused by noninvasive strains of Escherichia coli. XIFAXAN 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 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 was generally well tolerated. The most common side effects (vs. placebo) were flatulence 11.3% (vs. 19.7%), headache 9.7% (vs. 9.2%), abdominal pain 7.2% (vs. 10.1 %) and rectal tenesmus tenesmus /te·nes·mus/ (te-nez´mus) straining, especially ineffectual and painful straining at stool or urination.tenes´mic

te·nes·mus
n.
 7.2% (vs. 8.8%).

OSMOPREP(TM) Tablets (sodium phosphate monobasic monobasic /mono·ba·sic/ (-ba´sik) having but one atom of replaceable hydrogen.

mon·o·ba·sic
adj.
1. Having only one hydrogen ion to donate to a base in an acid-base reaction.
 monohydrate mon·o·hy·drate
n.
A compound, such as calcium chloride monohydrate, that contains one molecule of water.
, USP, and sodium phosphate dibasic dibasic /di·ba·sic/ (di-ba´sik) containing two replaceable hydrogen atoms, or furnishing two hydrogen ions.

di·ba·sic
adj.
1. Containing two replaceable hydrogen atoms.

2.
 anhydrous, USP) are indicated for cleansing of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable caution should be advised before OsmoPrep Tablets are used in patients with severe renal insufficiency, congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. , ascites, unstable angina, gastric retention, ileus Ileus Definition

Ileus is a partial or complete non-mechanical blockage of the small and/or large intestine. The term "ileus" comes from the Latin word for colic.
, acute obstruction or pseudo-obstruction of the bowel, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal function, patients with a history of acute phosphate nephropathy, known or suspected electrolyte disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as hypernatremia Hypernatremia Definition

The normal concentration of sodium in the blood plasma is 136-145 mM. Hypernatremia is defined as a serum sodium level over 145 mM. Severe hypernatremia, with serum sodium above 152 mM, can result in seizures and death.
, hyperphosphatemia, hypokalemia Hypokalemia Definition

Hypokalemia is a condition of below normal levels of potassium in the blood serum. Potassium, a necessary electrolyte, facilitates nerve impulse conduction and the contraction of skeletal and smooth muscles, including the heart.
, or hypocalcemia Hypocalcemia Definition

Hypocalcemia, a low bood calcium level, occurs when the concentration of free calcium ions in the blood falls below 4.0 mg/dL (dL = one tenth of a liter). The normal concentration of free calcium ions in the blood serum is 4.0-6.
 should have their electrolytes corrected before treatment with OsmoPrep Tablets.

VISICOL(R) Tablets (sodium phosphate monobasic monohydrate, USP, sodium phosphate dibasic anhydrous, USP) are indicated for cleansing of the bowel as a preparation for colonoscopy, in adults 18 years of age or older. VISICOL(R) Tablets are the only FDA approved tablets available to adults for bowel preparation prior to colonoscopy. VISICOL Tablets are virtually taste-free, can be taken with any clear liquid such as water, lemonade or ginger ale, and have been proven to be associated with significantly less nausea, vomiting and bloating than the leading, currently-available, prescribed class of liquid bowel preparations. VISICOL Tablets are not to be used in patients with congestive heart failure, ascites, unstable angina pectoris, gastric retention, ileus or acute obstruction or pseudo-obstruction, severe chronic constipation, bowel perforation, acute colitis, toxic megacolon or hypomotility syndrome. Use with caution in patients with impaired renal function, pre-existing electrolyte disturbances, or people taking drugs that affect electrolyte levels.

Salix also markets COLAZAL(R) Capsules 750 mg, AZASAN(R), Anusol-HC(R) Cream 2.5%, Anusol-HC(R) 25 mg Suppository suppository /sup·pos·i·to·ry/ (su-poz´i-tor?e) an easily fusible medicated mass to be introduced into a body orifice, as the rectum, urethra, or vagina.

sup·pos·i·to·ry
n.
, Proctocort(R) Cream 1% and Proctocort(R) Suppositories suppositories,
n.pl solid capsules made of materials that melt at body temperature and are used to deliver medicinal substances into the rectum.
. MOVIPREP(R) and granulated mesalamine are under development.

Salix trades on the NASDAQ National Market under the ticker symbol "SLXP".

For more information on Salix please call 919-862-1000 or visit www.salix.com. Information on the web site is not incorporated in Salix'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 sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association The American Gastroenterological Association is a medical association of gastroenterologists. About 14,000 scientists and physicians are members of the organization, which was founded in 1897 and is the oldest medical association in the United States. , the American Society for Gastrointestinal Endoscopy The American Society for Gastrointestinal Endoscopy, or ASGE, is a professional organization of physicians dedicated to improving endoscopy. The ASGE is made up largely of gastroenterologists from the United States.  and the Society for Surgery of the Alimentary Tract, DDW takes place May 20-25, 2006, at the Los Angeles Convention Center The Los Angeles Convention Center (abbreviated LACC) is a convention center in downtown Los Angeles. The LACC hosts annual events such as the Greater Los Angeles Auto Show, and was best known to video games fans as host to E3 until its cessation in 2006. . The meeting showcases approximately 5,000 abstracts and 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-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include risks of regulatory review and clinical trials, intellectual property risks, rapid growth and the need to acquire additional products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:May 23, 2006
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