Salix Announces Completion of OsmoPrep(TM) versus Liquid Bowel Cleanser Comparison Study; Study Results Highly Statistically Significant (p less than 0.0001).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 the successful completion and outcome of a multi-center superiority trial to compare the colon cleansing, patient tolerability, patient preference and safety profile of the Company's recently-approved OsmoPrep(TM) Tablets and HalfLytely(R) with Bisacodyl Tablets Bowel Prep Kit. The Company-sponsored, investigator-blinded, randomized trial evaluated 411 patients completing scheduled colonoscopy. The primary endpoint of the study was the demonstration of superior colon cleansing efficacy of 48 gm (32 tablets) OsmoPrep compared to that of 2 liters HalfLytely and Bisacodyl Tablets Bowel Prep Kit. In this study, a significantly greater percentage of patients who used OsmoPrep recorded a mean overall colon cleansing score of "EXCELLENT" compared to the percentage of patients who used HalfLytely Bowel Prep (p less than 0.0001). Complete study results will be reported later this year. Commenting on the study results, Bill Forbes, Pharm. D., Vice President, Research and Development, and Chief Development Officer, stated, "This prospectively designed comparative trial of OsmoPrep versus HalfLytely supports the strengths of our product. The data from this comparative trial demonstrate that OsmoPrep should offer a viable solution for physicians and patients desiring an effective and tolerable tablet bowel cleansing agent." Salix intends to launch OsmoPrep to physicians during the second half of June 2006. Two posters discussing results of trials evaluating OsmoPrep colon cleansing will be presented at Digestive Disease Week 2006, May 20-25, in Los Angeles, CA. Colorectal Cancer Screening The majority of colonoscopies performed in the United States are indicated for colorectal cancer screening, and more than 10 million uses of bowel cleansing agents were prescribed during 2005. Today less than half of adults age 50 and older in the U.S. undergo recommended colorectal cancer screening. Colonoscopy is very effective in the early detection of colorectal cancer, and about 90% of colorectal cancers and deaths are preventable if detected early. The American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, estimates that more than 30,000 lives could be saved annually as a result of widespread screening. Results of a study conducted by the Mayo Clinic demonstrated that patient unwillingness to take a bowel preparation is the single largest barrier to colorectal cancer screening. Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, 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. 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. Salix also markets COLAZAL(R) (balsalazide disodium) Capsules 750 mg, XIFAXAN(R) (rifaximin) tablets 200 mg, VISICOL(R) Tablets (sodium phosphate monobasic monohydrate, USP, sodium phosphate dibasic anhydrous, USP), AZASAN(R) (azathioprine azathioprine: see metabolite. 75mg and 100mg tablets, USP), Anusol-HC(R) 2.5% (hydrocortisone hydrocortisone (hī'drəkôr`tĭzōn'), another name for the steroid hormone cortisol, more especially used to refer to preparations of this hormone used medicinally. Cream USP), 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. (Hydrocortisone Acetate), Proctocort(R) Cream (Hydrocortisone Cream USP) 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. (Hydrocortisone Acetate Rectal Suppositories, 30 mg). MOVIPREP(R) and granulated mesalamine are under development. For full prescribing information on Salix products, please visit www.salix.com. Salix trades on the Nasdaq National Market under the ticker symbol "SLXP". For more information please contact the Company at 919-862-1000 or visit our web site at www.salix.com. Information on our web site is not incorporated in our SEC filings. AZASAN(R) is a registered trademark of AAI Properties Inc. HALFLYTELY(R) and Bisacodyl Tablets Bowel Prep Kit is a registered trademark of Braintree Laboratories, Inc. 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 risk of clinical trails and regulatory review, market acceptance for approved products, management of rapid growth, intellectual property risks, 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. |
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