Positive Results with ZEGERID in Nocturnal Acid Breakthrough Clinical Study

SAN DIEGO -- Santarus, Inc., a specialty pharmaceutical company focused on therapies for gastrointestinal diseases and disorders, 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 percent experienced NAB while treated with ZEGERID compared to 92 percent 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, MD, division of gastroenterology, Albert Einstein Medical Center, was the study's lead investigator.

About ZEGERID
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.

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.

Source: Business Wire

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