FDAnews Drug Daily Bulletin

AstraZeneca has submitted an sNDA for Nexium IV to treat patients with peptic ulcer bleeding after endoscopy.

The submission incorporates data from the Nexium IV (esomeprazole sodium) peptic ulcer bleed study, a randomized trial of 767 patients, the company says. The study’s primary objective was to compare the rate of clinically significant rebleeding of patients within 72 hours of starting Nexium IV treatment with placebo.

Secondary objectives included endoscopic retreatment due to rebleeding, surgery, hospitalization, blood transfusions, mortality and safety outcomes.

Patients received an IV infusion of Nexium 80 mg for 30 minutes plus an IV infusion of Nexium 8 mg per hour for 72 hours, followed by oral Nexium (esomeprazole magnesium) 40 mg once daily for 27 days. The control group received an IV infusion of placebo for 72 hours, followed by the same 27-day regimen of oral Nexium.

Nexium IV for injection is approved for short-term treatment of gastroesophageal reflux disease in patients with a history of erosive esophagitis when therapy with Nexium delayed-release capsules is not possible or appropriate.

If approved, Nexium IV would be the first proton pump inhibitor therapy for this indication, according to AstraZeneca.