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news.AstraZeneca has submitted a new drug application to the FDA seeking approval for a product combining low dose aspirin with esomeprazole magnesium for the risk reduction of low dose aspirin-associated gastric and/or duodenal ulcers in patients at risk.
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AstraZeneca has also submitted a supplemental new drug application (sNDA) for Nexium for the risk reduction of low dose aspirin-associated gastric and/or duodenal ulcers.
Nexium already is approved for the risk reduction in the occurrence of gastric ulcers associated with continuous non-steroidal anti-inflammatory drug therapy in patients at risk for developing gastric ulcers.
AstraZeneca has conducted two studies to evaluate the safety and efficacy of Nexium in reducing the risk of gastric and/or duodenal ulcers in patients who take low dose aspirin (75-325mg continuously during the study, which is defined as at least five days per week). One study compared Nexium 40mg or 20mg with placebo, while the other study compared Nexium 20mg with placebo. Both the NDA and sNDA submissions are based on the results of these studies.