Santarus Announces DDW Clinical Abstract Regarding Nighttime Acid Control; Clinical Study Evaluated ZEGERID and Leading PPI Brands Nexium and Prevacid.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 diseases and disorders, today announced that new clinical data were presented in a poster session at the Digestive Diseases Week (DDW DDW Digestive Disease Week DDW Diseases of the Developing World DDW Dimensional Data Warehouse DDW Digital Data Warfare DDW Darkness Does Wonders (bar slang) DDW Data Driven Workflow ) meeting on May 21, 2006. The clinical study evaluated nighttime gastric acidity in patients with nocturnal symptoms 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 GERD gastroesophageal reflux disease. GERD abbr. gastroesophageal reflux disease GERD ) who were treated with ZEGERID(R) (omeprazole/sodium bicarbonate) Powder for Oral Suspension 40 mg, Nexium(R) (esomeprazole magnesium es·o·mep·ra·zole magnesium n. A drug of the proton pump inhibitor class. esomeprazole magnesium Nexium Pharmacologic class: Proton pump inhibitor Therapeutic class: ) delayed-release capsules 40 mg and Prevacid(R) (lansoprazole) delayed-release capsules 30 mg on an empty stomach at bedtime. The results indicated that patients treated with ZEGERID experienced significantly fewer episodes of nocturnal acid breakthrough (NAB) than with the comparator comparator Instrument for comparing something with a similar thing or with a standard measure, in particular to measure small displacements in mechanical devices. In astronomy, the blink comparator is used to examine photographic plates for signs of moving bodies. drugs, and that dosing ZEGERID at bedtime on an empty stomach provided more rapid control of gastric acid gastric acid, n the hydrochloric acid secreted by the gastric glands in the stomach; aids in the preparation of food for digestion. in the first half of the night, a critical period for acid control. 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). ) therapy controls gastric acidity by reducing the production of gastric acid. A measure of gastric acid control is the ability of a therapy to maintain gastric pH at a level greater than 4 during the day and at night. The primary endpoint of the open-label, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , crossover clinical study was the occurrence of NAB, defined as gastric pH less than 4 for more than one continuous hour during PPI therapy between 10:00 p.m. and 6:00 a.m. Additional endpoints of the clinical study were the percentage of time gastric pH was greater than 4 and median gastric pH, which were evaluated in cumulative two-hour intervals during the nighttime hours. The abstract is titled: "Nocturnal Gastric Acidity After Bedtime Dosing of Proton Pump Inhibitors Proton Pump Inhibitors Definition The proton pump inhibitors are a group of drugs that reduce the secretion of gastric (stomach) acid. They act by binding with the enzyme H+, K(+)-ATPase, hydrogen/potassium adenosine triphosphatase in Patients with Nighttime GERD Symptoms." Philip O. Katz, M.D., Division of Gastroenterology, Albert Einstein Medical Center, was the study's lead investigator. Data were evaluated after seven continuous days of once-daily bedtime dosing. Selected observations from the clinical study are summarized below: --In an analysis of the primary endpoint data from 49 patients, only 61 percent experienced NAB while treated with ZEGERID compared to 92 percent of patients treated with Nexium and 92 percent of patients treated with Prevacid, p less than 0.001 for both comparisons. This means that 50 percent more patients experienced nighttime acid breakthrough with either Nexium or Prevacid than with ZEGERID. --Bedtime administration of ZEGERID produced a rapid rise in gastric pH that was not observed with either delayed-release PPI. The results indicated that the percentage of time gastric pH was greater than 4 when evaluated for the first half of the night (10:00 p.m. to 2:00 a.m.) was 52 percent for ZEGERID, 30 percent for Nexium and 12 percent for Prevacid, p less than 0.001 for both comparisons. --Each study drug was well tolerated, and there were no notable differences between the adverse events reported for the different treatments. "Recently published independent clinical research indicates that episodes of nocturnal acid reflux are more frequent in the first half of the night when patients with GERD lie down to sleep. When taken at bedtime on an empty stomach, ZEGERID Powder for Oral Suspension rapidly increases gastric pH during the first half of the night and provides sustained nighttime acid control," said Gerald T. Proehl, president and chief executive officer of Santarus. "The results of this clinical study are encouraging and further support our belief that our immediate-release ZEGERID products offer patients flexible dosing and an attractive treatment option for daytime or nighttime acid control." PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. Immediate-release ZEGERID Capsules and ZEGERID Powder for Oral Suspension provide rapid and sustained control of gastric acidity when administered once daily on an empty stomach (at least one hour before a meal), including at bedtime. All other currently marketed oral PPIs are delayed-release products that use an enteric coating to protect the PPI from gastric acid degradation. Unlike delayed-release PPIs, ZEGERID products utilize one or more antacids Antacids Definition Antacids are medicines that neutralize stomach acid. Purpose Antacids are used to relieve acid indigestion, upset stomach, sour stomach, and heartburn. in lieu of an enteric coating to protect the PPI, omeprazole, from gastric acid degradation. The antacids neutralize stomach acid and protect the omeprazole from gastric acid degradation and allow for its rapid absorption and suppression of gastric acid. Important Safety Information ZEGERID (omeprazole/sodium bicarbonate) Capsules and Powder for Oral Suspension contain a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid antacid, any one of several basic substances that counteract stomach acidity (see stomach). Antacids are used by physicians to treat hyperchlorhydria, i.e., the excessive production of hydrochloric acid by the parietal cells lining the stomach. , which raises the gastric pH and thus protects the omeprazole from acid degradation. 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 Capsules contain 300 mg of sodium per dose in the form of sodium bicarbonate (1100 mg/13 mEq) and ZEGERID Powder for Oral Suspension contains 460 mg of sodium per dose in the form of sodium bicarbonate (1680 mg/20 mEq). This 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 hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. to any component of the formulation. About DDW DDW is the largest gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy endoscopy Examination of the body's interior through an instrument inserted into a natural opening or an incision, usually as an outpatient procedure. Endoscopes include the upper gastrointestinal endoscope (for the esophagus, stomach, and duodenum), the colonoscope (for the and gastrointestinal surgery. The conference is jointly sponsored by four medical societies: 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. More information on the annual meeting is available at www.ddw.org. About Santarus Santarus, Inc. is a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products that treat gastrointestinal diseases and disorders and enhance the quality of life for patients. The company's products are immediate-release formulations of omeprazole, a widely prescribed PPI. The company's marketed products include ZEGERID Capsules (launched in late March 2006) and ZEGERID Powder for Oral Suspension. Santarus received 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. ) approval for its third dosage form, ZEGERID with Magnesium Hydroxide (omeprazole/sodium bicarbonate/magnesium hydroxide) Chewable Tablets, in March 2006. 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 Santarus' products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; Santarus' ability to drive market demand for and generate increased commercial sales of ZEGERID Capsules and ZEGERID Powder for Oral Suspension and any other products that may be marketed; competition from other pharmaceutical or biotechnology companies; other difficulties or delays relating to the development, testing, manufacturing and marketing of 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. All other trademarks appearing in this press release are the property of their respective owners. |
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