Santarus: Study shows Zegerid more effective against nocturnal acid breakthrough than Prevacid

By E. Janene Geiss

Philadelphia, March 8 - Santarus, Inc. announced Wednesday 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 when given to patients with nocturnal symptoms of gastroesophageal reflux disease on an empty stomach at bedtime.

Proton pump inhibitor 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, according to a company news release.

The primary endpoint of the open-label, randomized, crossover study was the occurrence of nocturnal acid breakthrough, defined as gastric pH less than 4 for more than one continuous hour overnight during proton pump inhibitor therapy.

Of the 49 patients who completed the study, 61% experienced acid breakthrough while treated with Zegerid compared to 92% who experienced acid breakthrough while being treated with either Nexium or Prevacid, officials said.

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, officials said.

"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, in a news release.

Santarus is a San Diego 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.

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