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AstraZeneca Submits sNDA for NEXIUM(R) I.V. for Peptic Ulcer Bleed Indication

WILMINGTON, Del., May 30 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for NEXIUM(R) 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).(1) To date, there is no proton pump inhibitor (PPI) therapy globally approved for this indication.(2) 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.(3)

Peptic ulcer bleeding can be a life-threatening complication of peptic ulcer disease that affects approximately 50 people per 100,000 each year.(4 5 6 7) 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.(4 6 7 8 9)

The NEXIUM(R) 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.(1) 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.(2) Secondary end points measured the rate of re-bleeding within seven and 30 days.(2) 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.(2) The study was performed at 91 centers in 16 countries across Europe, Africa and Asia.

About Peptic Ulcer Bleed (PUB)

PUB is a potentially life-threatening event that occurs as a result of peptic ulcer disease. PUB occurs when the ulcer erodes into an underlying blood vessel. The resulting blood loss can be significant as clotting can be impaired in the acidic environment. If after treatment, a peptic ulcer re-bleeds, there is an increased risk of morbidity and mortality(8) and associated healthcare costs.(10 11)

About NEXIUM(R) I.V. (esomeprazole sodium) for Injection

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 Delayed-Release Capsules is not possible or appropriate.

When oral therapy is possible or appropriate, intravenous therapy with NEXIUM I.V. for Injection should be discontinued and the therapy should be continued orally.

The recommended adult dose is either 20 or 40 mg esomeprazole given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 to 30 minutes).

NEXIUM I.V. for Injection should not be administered concomitantly with any other medications through the same intravenous site and or tubing. The intravenous line should always be flushed with either 0.9% Sodium Chloride Injection, USP, Lactated Ringer's Injection, USP or 5% Dextrose Injection, USP both prior to and after administration of NEXIUM I.V. for Injection.

Treatment with NEXIUM I.V. for Injection should be discontinued as soon as the patient is able to resume treatment with NEXIUM Delayed-Release Capsules. Safety and efficacy of NEXIUM I.V. for Injection as a treatment of GERD patients with a history of erosive esophagitis for more than 10 days have not been demonstrated.

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About NEXIUM(R) (esomeprazole magnesium) Delayed-Release Capsules

In adults, NEXIUM is approved for treating frequent, persistent heartburn and other symptoms associated with acid reflux disease as well as healing erosive esophagitis. Most erosions heal in four to eight weeks. Individual results may vary, and only a doctor can determine if erosions to the esophagus have occurred. Symptom relief does not rule out the existence of other serious stomach conditions.

NEXIUM received approval in April 2006 for the short-term treatment (up to 8 weeks) of GERD in adolescent patients ages 12 to 17 years old. NEXIUM is now approved for the short-term treatment (up to 8 weeks) of GERD in children ages 1 to 11 years old. The approvals are supported by extrapolation of results from adequate and well-controlled studies that supported the approval of NEXIUM for adults, and safety and pharmacokinetic studies. The safety and effectiveness of NEXIUM for the treatment of GERD in patients less than 1 year of age have not been established. The safety and effectiveness of NEXIUM for other pediatric uses have not been established.

In adults, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, and abdominal pain. In patients 1 to 17 years of age, the most frequently reported adverse reactions with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence. Symptomatic response to therapy does not preclude the presence of gastric malignancy. NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information.

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For additional information, questions, or to request a copy of the NEXIUM prescribing information, please contact the Information Center at AstraZeneca at 1-800-236-9933, Monday through Friday, from 8 a.m. to 7 p.m. ET, excluding holidays.


NEXIUM and NEXIUM I.V. are contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles.

The most frequently reported adverse events with NEXIUM include headache, diarrhea, and abdominal pain. Injection site reactions have also been reported with NEXIUM I.V.

Symptomatic response to therapy does not preclude the presence of gastric malignancy.

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which NEXIUM is an enantiomer.

As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Like other proton pump inhibitors, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts, and digoxin). Concomitant administration of esomeprazole may reduce the plasma levels of atazanavir.

NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. Please see full Prescribing Information for NEXIUM.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.35 billion healthcare business with 12,200 employees committed to improving people's lives. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.
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(1) Data on File. AstraZeneca Pharmaceuticals LP. 263698.

(2) J. J.Y. Sung et al. Intravenous esomeprazole for prevention of peptic

ulcer re-bleeding: rationale/design of the Peptic Ulcer Bleed study.

Aliment Pharmacol Ther 2008; 27:666-677.

(3) NEXIUM I.V. Prescribing Information. Indications and usage section.

(4) Lassen et al. Complicated and uncomplicated peptic ulcers in a Danish

county 1993-2002: a population-based cohort study. Am J Gastroenterol


(5) Kang JY et al. Recent trends in hospital admissions and mortality

rates for peptic ulcer in Scotland 1982-2002. Aliment Pharmacol Ther


(6) Soplepmann et al. Peptic ulcer haemorrhage in Tartu County, Estonia:

epidemiology and mortality risk factors. Scand J Gastroenterol


(7) Thomsen et al. Diabetes and 30-day mortality from peptic ulcer

bleeding and perforation: a Danish population-based cohort study.

Diabetes Care 2006;29(4):805-10.

(8) van Leerdam ME et al Acute upper GI bleeding: Did anything change?

Time trend analysis of incidence and outcome of acute upper GI

bleeding between 1993/1994 and 2000. American Journal of

Gastroenterology 2003;98(7):1494-1499. Table 5.

(9) Mose et al. Thirty-day mortality after peptic ulcer bleeding in

hospitalized patients receiving low-dose aspirin at time of

admission. Am J Geriatr Pharmacother 2006;4(3):244-50.

(10) Barkun et al. The cost-effectiveness of high-dose oral proton pump

inhibition after endoscopy in the acute treatment of peptic ulcer

bleeding. Aliment Pharmacol Ther 2004; 20: 195-202.

(11) Barkun et al. High-dose intravenous proton pump inhibition following

endoscopic therapy in the acute management of patients with bleeding

peptic ulcers in the USA and Canada: a cost-effectiveness analysis

Aliment Pharmacol Ther 2004; 19: 591-600.

SOURCE AstraZeneca
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