Santarus: Data show Zegerid controls nighttime acid reflux better than Nexium, Prevacid

By E. Janene Geiss

Philadelphia, May 22 - Santarus, Inc. said Monday that new clinical data evaluating nighttime gastric acidity associated with nocturnal symptoms of gastroenterological reflux disease shows that patients treated with Zegerid experienced significantly fewer episodes of nocturnal acid breakthrough than with the comparator drugs.

The data also show that dosing Zegerid at bedtime on an empty stomach provided more rapid control of gastric acid in the first half of the night, a critical period for acid control, according to a company news release.

Patients in the study were treated with Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension 40 mg, Nexium (esomeprazole magnesium) delayed-release 40 mg capsules and Prevacid (lansoprazole) delayed-release 30 mg capsules, officials said.

The data were presented Sunday at the Digestive Diseases Week meeting.

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 four during the day and at night, officials said.

The primary endpoint of the open-label, randomized, crossover clinical study was the occurrence of nocturnal acid breakthrough, defined as gastric pH less than four, for more than one continuous hour during proton pump inhibitor therapy between 10 p.m. and 6 a.m., officials said.

Additional endpoints were the percentage of time gastric pH was greater than four and median gastric pH, which were evaluated in cumulative two-hour intervals during the nighttime hours.

Data were evaluated after seven continuous days of once-daily bedtime dosing.

In an analysis of the primary endpoint data from 49 patients, only 61% experienced nocturnal acid breakthrough while treated with Zegerid compared to 92% of patients treated with Nexium and 92% of patients treated with Prevacid, officials said. This means that 50% more patients experienced nighttime acid breakthrough with either Nexium or Prevacid than with Zegerid.

Bedtime administration of Zegerid produced a rapid rise in gastric pH that was not observed with either delayed-release proton pump inhibitor, officials said.

The results indicated that the percentage of time gastric pH was greater than four when evaluated for the first half of the night was 52% for Zegerid, 30% for Nexium and 12% for Prevacid, officials said.

Each study drug was well-tolerated and there were no notable differences between the adverse events reported for the different treatments, officials said.

Santarus is a San Diego specialty pharmaceutical company focused on developing products that treat gastrointestinal diseases and disorders.

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