AstraZeneca has announced the submission of a supplemental New Drug Application (sNDA) to the FDA for NEXIUM® I.V. (esomeprazole sodium) for Injection to seek approval for use in patients with peptic ulcer bleeding (PUB) following therapeutic endoscopy. The regulatory submission incorporates data from the NEXIUM I.V. Peptic Ulcer Bleed study, a multinational, randomized trial of 767 patients with peptic ulcer bleeding (PUB). To date, there is no proton pump inhibitor (PPI) therapy globally approved for this indication. Presently, NEXIUM I.V. for Injection is indicated for the short-term treatment (up to 10 days) of GERD adult patients with a history of erosive esophagitis, as an alternative to oral therapy in patients when therapy with NEXIUM(R) (esomeprazole magnesium) Delayed-Release Capsules is not possible or appropriate. Peptic ulcer bleeding can be a life-threatening complication of peptic ulcer disease that affects approximately 50 people per 100,000 each year. Patients experiencing re-bleeding after initial treatment of peptic ulcer bleeding have a greater than 3-fold risk of death,(8) and up to 14 percent of patients suffering an acute bleed die. The NEXIUM® I.V. (esomeprazole sodium) Peptic Ulcer Bleed study was a prospective multinational, randomized, placebo-controlled, double-blind trial of 767 men and women, ages 18 years or older, who had undergone successful endoscopic treatment of a bleeding gastric or duodenal ulcer. The primary objective was to compare the rate of clinically significant re-bleeding of patients within 72 hours of starting NEXIUM I.V. treatment, compared with placebo. Secondary objectives included endoscopic re-treatment due to re-bleeding, surgery, hospitalization, blood transfusions, mortality, and safety outcomes. Secondary end points measured the rate of re-bleeding within seven and 30 days. Patients received an I.V. infusion of NEXIUM 80 mg over 30 minutes plus an I.V. infusion of NEXIUM 8 mg/hour for 72 hours, followed by oral NEXIUM 40 mg once daily for 27 days. A control group received an I.V. infusion of placebo for 72 hours followed by the same 27-day period of oral NEXIUM. The study was performed at 91 centers in 16 countries across Europe, Africa and Asia.
