Business Wire - Santarus Announces Presentation of Clinical Data Comparing ZEGERID Powder for Oral Suspension and Protonix in Reducing Nighttime Gastric Acidity in GERD…
SAN DIEGO & ORLANDO, Fla. — Santarus, Inc. (NASDAQ:SNTS), a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, today announced the presentation of results from a clinical trial comparing the effects of ZEGERID(TM) immediate-release omeprazole suspension and Protonix(R) delayed-release pantoprazole tablets on nocturnal gastric acidity. Both drugs are proton pump inhibitors (PPIs) used to reduce gastric acid and prevent symptoms of gastroesophageal reflux disease (GERD). The trial results were presented in a poster session on October 31, 2004 at the 69th Annual Scientific Meeting of the American College of Gastroenterology (ACG). The poster was selected as a winner of the ACG Presidential Poster Award, a designation reserved for posters scoring in the top five percent of submitted abstracts.
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“The results of the study demonstrate that nocturnal acid breakthrough, which generally occurs during treatment with delayed-release PPIs, was markedly decreased after once-daily dosing at bedtime with ZEGERID,” said Donald Castell, MD, professor of medicine and director, Esophageal Disorders Program at Medical University of South Carolina. Dr. Castell is past president of the American Gastroenterological Association and lead author of the abstract and poster. “A recent survey showed that 79 percent of GERD patients reported experiencing nighttime heartburn, resulting in sleeping difficulties and impaired next day function.”
In this study, 36 patients with nocturnal symptoms of GERD were enrolled in an open-label crossover trial. The patients were randomized to be treated with repeated evening doses of either ZEGERID Powder for Oral Suspension or Protonix Delayed-Release Tablets for one week, followed by a day of twice-daily dosing. After a washout period of one week, patients were treated with the alternate drug, following the same schedule. ZEGERID 40mg and Protonix 40mg were used for once-daily dosing. ZEGERID 20mg and 40mg and Protonix 40mg were used for twice-daily dosing.
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 dosing of ZEGERID 40mg on six consecutive days, with 24-hour pH monitoring beginning at the last dose. Gastric acidity was measured over an 8-hour nighttime interval and over 24 hours.
Data from 32 patients were available for analysis. After repeated once-daily dosing, ZEGERID produced statistically significantly better nocturnal gastric acid control than Protonix: median gastric pH 4.7 vs. 2; percent time gastric pH was greater than 4, 55 vs. 27; patients with nocturnal acid breakthrough (NAB) 53 percent vs. 78 percent (P less than 0.001 for all comparisons). After twice-daily dosing, ZEGERID 20mg produced statistically significantly better nocturnal gastric acid control than Protonix 40mg: median gastric pH 5.8 vs. 1.9; percent time gastric pH was greater than 4, 79 vs. 31; patients with NAB 47 percent vs. 80 percent (P less than or equal to 0.025 for all comparisons). For the 40-mg doses of the two drugs, ZEGERID and Protonix, respectively: median gastric pH 6.5 vs. 1.5; percent time gastric pH was greater than 4, 92 vs. 37; patients with NAB 12 percent vs. 71 percent (P less than 0.001 for all comparisons).
After once-daily bedtime dosing of ZEGERID 40mg and twice-daily dosing of Protonix 40mg, twenty-four hour pH control was not significantly different (percent time gastric pH was greater than 4: ZEGERID 61 percent, Protonix 56 percent). Twenty-four hour pH control was significantly better after twice-daily dosing of ZEGERID 20mg than after twice-daily dosing of Protonix 40mg (percent time gastric pH was greater than 4: ZEGERID 68 percent, Protonix 51 percent; P less than 0.001).
Important Safety Information
A new drug application (NDA) for ZEGERID Powder for Oral Suspension 40mg is currently under review by the U.S. Food and Drug Administration (FDA), and that dose strength has not been approved by the FDA for marketing.
ZEGERID Powder for Oral Suspension 20mg is indicated for short-term treatment of active duodenal ulcer, for heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), for the short-term treatment (4-8 weeks) of erosive esophagitis which has been 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 component of the formulation. ZEGERID Powder for Oral Suspension 20mg is recommended for once-daily dosing, on an empty stomach one hour prior to a meal.
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.
