Santarus Announces Publication of Peer-Reviewed Journal Articles on ZEGERID in Treating Upper GI Diseases and Disorders.SAN DIEGO -- Santarus, Inc. (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 :SNTS SNTS Society for New Testament Studies SNTS Standalone NMD Training System ), a specialty pharmaceutical company focused on therapies for gastrointestinal (GI) diseases and disorders, today announced the publication of three articles in peer-reviewed journals, which include reviews and discussions of the company's ZEGERID(R) Powder for Oral Suspension product, an immediate-release formulation of omeprazole, a proton pump inhibitor proton pump inhibitor n. A class of drugs that inhibit gastric acid secretion by interfering with the movement of hydrogen ions across cell membranes and are used mainly to treat peptic ulcers, gastroesophageal reflux disease, and esophagitis. (PPI (1) (Pixels Per Inch) The measurement of the resolution of a monitor or scanner. For example, a monitor that is 16 inches wide and displays 1600 pixels across its width would have a resolution of 100 ppi (1600 divided by 16). ). In addition, the proceedings of a Santarus-sponsored roundtable were published in a supplement to a peer-reviewed gastroenterology journal. The three recently published journal articles are: --"Review of Immediate-Release Omeprazole for the Treatment of Gastric Acid-Related Disorders," which was published in the November 2005 issue of Expert Opinion on Pharmacotherapy pharmacotherapy /phar·ma·co·ther·a·py/ (-ther´ah-pe) treatment of disease with medicines. phar·ma·co·ther·a·py n. Treatment of disease through the use of drugs. . ZEGERID Powder for Oral Suspension was reviewed by Donald Castell, MD, Professor of Medicine and Director, Esophageal Disorders Program at the Medical University of South Carolina “MUSC” redirects here. For Abel Santa María airport in Santa Clara, Cuba (ICAO code MUSC), see Abel Santa María Airport. The Medical University of South Carolina , past president of 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. and a member of the Santarus Medical Advisory Board. --"Nocturnal Reflux: Assessing and Addressing the Problem," which was published in the December 2005 issue of Practical Gastroenterology. This article is part of the series "GERD GERD gastroesophageal reflux disease. GERD abbr. gastroesophageal reflux disease GERD in the 21st Century" and was written by Philip O. Katz, MD, Chairman, Division of Gastroenterology, Albert Einstein Medical Center. It includes a discussion of ZEGERID Powder for Oral Suspension in controlling nighttime acidity. --"Advances in Proton Pump Inhibitor Therapy: An Immediate-Release Formulation of Omeprazole," which was published in Pharmacy & Therapeutics, December 2005. The article was written by Ralph E. Small, Pharm.D., Professor Emeritus, Virginia Commonwealth University Formed by a merger between the Richmond Professional Institute and the Medical College of Virginia in 1968, VCU has a medical school that is home to the nation's oldest organ transplant program. . The proceedings of the roundtable discussions were published as a supplement to the December 2005 issue of Alimentary alimentary /al·i·men·ta·ry/ (al?i-men´tah-re) pertaining to food or nutritive material, or to the organs of digestion. al·i·men·ta·ry adj. 1. Pharmacology and Therapeutics. Nine articles were authored by 11 key opinion leaders in gastroenterology and cover a wide range of topics in the management of gastroesophageal reflux disease gastroesophageal reflux disease (GERD) Disorder characterized by frequent passage of gastric contents from the stomach back into the esophagus. Symptoms of GERD may include heartburn, coughing, frequent clearing of the throat, and difficulty in swallowing. (GERD) and upper GI bleeding in the critical care setting. The supplement is titled "Clinical Implications of Immediate-Release PPI Therapy in the Management of GERD and Upper GI Bleeding." A review of ZEGERID Powder for Oral Suspension clinical data is presented in five of the supplement articles. About ZEGERID PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. The immediate-release formulation of ZEGERID Powder for Oral Suspension produces rapid and sustained control of gastric acidity when administered once daily. Unlike delayed-release PPIs, ZEGERID Powder for Oral Suspension utilizes sodium bicarbonate in lieu of an enteric coating to protect the active ingredient from gastric acid degradation. The sodium bicarbonate buffers the active ingredient, omeprazole, and facilitates its rapid absorption and suppression of gastric acid. ZEGERID Powder for Oral Suspension 20 mg is indicated for heartburn and other symptoms associated with GERD, for the short-term treatment (four to eight weeks) of erosive e·ro·sive adj. Causing erosion. esophagitis esophagitis /esoph·a·gi·tis/ (e-sof?ah-ji´tis) inflammation of the esophagus. chronic peptic esophagitis reflux e. diagnosed by endoscopy, for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months) and for the short-term treatment (four to eight weeks) of active duodenal ulcer. ZEGERID Powder for Oral Suspension 40 mg is indicated for the short-term treatment (four to eight weeks) of active benign gastric ulcer and for reduction of risk of upper GI bleeding in critically ill patients (use beyond 14 days has not been evaluated). The most frequently reported adverse events with ZEGERID are headache, diarrhea, and abdominal pain. In critically ill patients treated with ZEGERID, adverse events generally reflected the serious, underlying medical condition of the patients and were similar for patients treated with ZEGERID and with the comparator (acid controlling) drug. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long term with omeprazole. ZEGERID contains 460 mg of sodium per dose in the form of sodium bicarbonate (1680 mg/20 mEq) which should be taken into consideration for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and 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. . ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation. About Santarus Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products to enhance the quality of life for patients with gastrointestinal diseases and disorders. The company's current products are immediate-release formulations of omeprazole, a widely prescribed PPI. The company launched its first product, ZEGERID Powder for Oral Suspension 20 mg, in October 2004 and launched ZEGERID Powder for Oral Suspension 40 mg in February 2005. The company submitted a New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for ZEGERID Capsules 40 mg and 20 mg to the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) in April 2005 and submitted an NDA for ZEGERID Chewable Tablets 40 mg and 20 mg to the FDA in May 2005. More information about Santarus is available on the company's Web site at www.santarus.com. Santarus cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Santarus that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Santarus' business, including, without limitation: unexpected adverse side effects or inadequate therapeutic efficacy of ZEGERID Powder for Oral Suspension or Santarus' other products under development that could delay or prevent product commercialization, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of and obtaining regulatory approval for Santarus' products; and other risks detailed in Santarus' prior press releases as well as in public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Santarus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. Santarus(R) and ZEGERID(R) are trademarks of Santarus, Inc. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion