Immediate-release Omeprazole Significantly Reduces Nocturnal Acidity
Jun 15, 2005 - 12:15:00 AM, Reviewed by: Dr.
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"ZEGERID's effectiveness in controlling nocturnal gastric acidity when dosed at bedtime is intriguing and worthy of further study. The goal of PPI use in the evening is to reduce nocturnal gastric acidity, which reduces the possibility of acid reflux in patients with GERD,"
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By Santarus, Inc.,
Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced the publication of clinical trial results in the June 15, 2005 issue of Alimentary Pharmacology & Therapeutics, a peer-reviewed gastroenterology journal.
The trial results showed that immediate-release ZEGERID(R) (omeprazole) Powder for Oral Suspension 40 mg significantly reduced gastric acidity throughout the night compared to Protonix(R) (pantoprazole) Delayed-Release Tablets 40 mg when dosed once a day in the evening. Both drugs are proton pump inhibitors (PPIs) used to reduce gastric acid and treat symptoms of gastroesophageal reflux disease (GERD).
"ZEGERID's effectiveness in controlling nocturnal gastric acidity when dosed at bedtime is intriguing and worthy of further study," said Donald Castell, MD, lead author on the article. "The goal of PPI use in the evening is to reduce nocturnal gastric acidity, which reduces the possibility of acid reflux in patients with GERD," Dr. Castell added. Dr. Castell is professor of medicine and director, Esophageal Disorders Program at the Medical University of South Carolina, and is past president of the American Gastroenterological Association.
In this study, 36 patients with nighttime symptoms of GERD participated in an open-label, randomized crossover trial. The patients received repeated evening doses of either ZEGERID or Protonix for one week, followed by twice-daily dosing for one day. After a washout period, patients were treated with the alternative drug, following the same schedule.
During once-daily dosing, ZEGERID was administered at bedtime; however, reflecting current practice for evening dosing of delayed-release PPIs, Protonix was administered before dinner. During twice-daily dosing, both drugs were administered before breakfast and at bedtime. The protocol allowed 18 patients to return for additional once-daily dosing of ZEGERID 40 mg on six consecutive days, with 24-hour pH monitoring beginning at the last dose. Gastric acidity was calculated separately over an 8-hour nighttime interval and over 24 hours.
Measurements included median gastric pH, percentage of time gastric pH was greater than 4 and percentage of patients with nocturnal acid breakthrough (NAB), defined as the occurrence of continuous gastric pH of less than 4 for more than one hour during the night while receiving PPI therapy. The amount of time that pH is greater than 4 is a parameter frequently used to evaluate the clinical effects of treatment with PPIs in patients with acid-related diseases.
Data from 32 patients were available for analysis. After repeated once-daily dosing, ZEGERID 40 mg produced significantly better nocturnal gastric acid control than Protonix 40 mg: median gastric pH was 4.7 vs. 2.0; the time with gastric pH greater than 4 was 55 percent vs. 27 percent; and patients with NAB totaled 53 percent vs. 78 percent (P less than or equal to 0.005 for all comparisons). After twice-daily dosing of ZEGERID 40 mg and Protonix 40 mg, respectively: median gastric pH was 6.5 vs. 1.5; the time with gastric pH greater than 4 was 92 percent vs. 37 percent; and patients with NAB totaled 12 percent vs. 71 percent (P less than or equal to 0.002 for all comparisons).
Once-daily bedtime dosing of ZEGERID 40 mg also achieved better nocturnal gastric acid control than twice-daily dosing of Protonix 40 mg: median gastric pH was 4.7 vs. 1.7 (P less than 0.001); the time with gastric pH greater than 4 was 55 percent vs. 34 percent (P less than 0.001); and patients with NAB totaled 53 percent vs. 75 percent (P = 0.035). In addition, ZEGERID 40 mg dosed once-daily achieved similar 24-hour pH control as Protonix 40 mg dosed twice-daily.
Important Safety Information
ZEGERID Powder for Oral Suspension 40 mg is indicated for reduction of risk of upper GI bleeding in critically ill patients and short-term treatment (four to eight weeks) of active benign gastric ulcers. ZEGERID Powder for Oral Suspension 20 mg is indicated for short-term treatment of active duodenal ulcers, for heartburn and other symptoms associated with GERD, for short-term treatment (four to eight weeks) of erosive esophagitis diagnosed by endoscopy, and for maintenance of healing of erosive esophagitis (controlled studies do not extend beyond 12 months). ZEGERID is contraindicated in patients with known hypersensitivity to any components of the formulation.
The most frequently reported adverse events with ZEGERID are headache, diarrhea and abdominal pain. 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. 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.
ZEGERID contains 460 mg sodium per dose in the form of sodium bicarbonate (1680 mg/20 mEq), which should be considered for patients on a sodium-restricted diet. Sodium bicarbonate is contraindicated in patients with metabolic alkalosis and hypocalcemia. 
- The Trial results were published in the June 15, 2005 issue of Alimentary Pharmacology & Therapeutics, a peer-reviewed gastroenterology journal.
www.santarus.com
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) for ZEGERID Capsules 40 mg and 20 mg to the U.S. Food and Drug Administration (FDA) 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: Santarus' ability to establish market acceptance and demand for ZEGERID Powder for Oral Suspension 40 mg and 20 mg; 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; 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(R) and ZEGERID(R) are trademarks of Santarus, Inc.
Contact Santarus, Inc. Martha L. Hough, 858-314-5824 Debra P. Crawford, 858-314-5708 or Investor Contact: Lippert/Heilshorn & Associates, Inc. Jody Cain or Bruce Voss, 310-691-7100 [email protected] [email protected] or Media Contact: Biosector 2 Sheryl Seapy, 949-608-0841
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