Healthcare Industry News: Protonix
News Release - March 8, 2006
Santarus Announces Positive Results with ZEGERID in Nocturnal Acid Breakthrough Clinical StudyClinical Study Evaluated ZEGERID and Major PPI Brands Nexium and Prevacid
SAN DIEGO--(HSMN NewsFeed)--March 8, 2006--Santarus, Inc. (NASDAQ:SNTS ), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced positive results from a recently completed clinical study that evaluated ZEGERID® (omeprazole/sodium bicarbonate) Powder for Oral Suspension 40 mg/1680 mg, Nexium® (esomeprazole magnesium) delayed-release capsules 40 mg and Prevacid® (lansoprazole) delayed-release capsules 30 mg with regard to reducing the occurrence of nocturnal acid breakthrough (NAB) when given to patients with nocturnal symptoms of gastroesophageal reflux disease (GERD) on an empty stomach at bedtime.
Proton pump inhibitor (PPI) 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, crossover study was the occurrence of NAB, defined as gastric pH less than 4 for more than one continuous hour overnight during PPI therapy. Of the 49 patients who completed the study, 61% experienced NAB while treated with ZEGERID compared to 92% who experienced NAB while being treated with either Nexium or Prevacid, p less than 0.001 for both comparisons. Data were evaluated after seven continuous days of once-daily dosing. Each study drug was well tolerated, and there were no notable differences between the adverse events reported for the different treatments. Philip O. Katz, M.D., Division of Gastroenterology, Albert Einstein Medical Center, was the study's lead investigator.
"The results of this clinical study, and our previously published clinical study evaluating ZEGERID and Protonix® (pantoprazole) delayed-release capsules in controlling nighttime acidity, are very encouraging for ZEGERID," said Gerald T. Proehl, president and chief executive officer of Santarus. "We believe that dosing ZEGERID Powder for Oral Suspension at bedtime offers physicians an excellent option for treating patients in need of nighttime gastric acid control."
ZEGERID Powder for Oral Suspension is an immediate-release PPI. PPIs are widely prescribed for a variety of diseases and disorders of the upper digestive tract. All currently marketed oral PPIs, other than ZEGERID, are delayed-release formulations that utilize an enteric coating to protect the PPI from acid degradation, thereby delaying absorption and initial acid suppression. Unlike delayed-release PPIs, ZEGERID utilizes sodium bicarbonate in lieu of an enteric coating. The sodium bicarbonate neutralizes stomach acid and protects the PPI, omeprazole, from gastric acid degradation and allows for its rapid absorption and suppression of gastric acid.
Important Safety Information
ZEGERID (omeprazole/sodium bicarbonate) contains a combination of omeprazole, a PPI, and sodium bicarbonate, an antacid, 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 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. ZEGERID is contraindicated in patients with known hypersensitivity to any component of the formulation.
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 currently markets ZEGERID Powder for Oral Suspension and received U.S. Food and Drug Administration (FDA) approval in February 2006 to market ZEGERID Capsules. Santarus submitted a New Drug Application for ZEGERID Chewable Tablets 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 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 of 1995.
Santarus® and ZEGERID® are trademarks of Santarus, Inc. All other trademarks appearing in this press release are the property of their respective owners.
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