Long-Term Safety Data Demonstrated Vimovo Is Generally Well Tolerated in Arthritis Patients at Risk for NSAID-Associated Gastric Ulcers

NATIONAL HARBOR, Md.--(BUSINESS WIRE)--Mar 25, 2011 - AstraZeneca (NYSE: AZN) today announced results from PN400-304, a long-term safety study of VIMOVO™ (naproxen/esomeprazole magnesium) 500/20 mg delayed-release tablets in osteoarthritis patients requiring daily nonsteroidal anti-inflammatory drug (NSAID) therapy who were at risk for NSAID-associated gastric ulcers.1 The data demonstrated VIMOVO was generally well tolerated throughout the 12-month treatment period, with no new or unexpected safety issues.1 Study findings were presented at the American Academy of Pain Medicine (AAPM) Annual Meeting in National Harbor, MD, and published in Current Medical Research and Opinion, the international, peer reviewed clinical research journal.2

While NSAIDs are commonly prescribed for relief of pain and inflammation in patients with osteoarthritis, long-term use may increase the occurrence of gastric ulcers and other adverse events (AEs) in some patients.3 VIMOVO, codeveloped by AstraZeneca and POZEN Inc, is a fixed-dose combination of enteric-coated naproxen, a pain-relieving NSAID, and immediate-release esomeprazole magnesium, an ulcer risk-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS), and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.4 VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.3

“Many of the 27 million patients in the United States diagnosed with osteoarthritis5 routinely take NSAIDs to help treat their pain and inflammation. While these treatments are effective in alleviating pain, chronic use of NSAIDs puts patients at increased risk of developing gastric ulcers2,” said Mark Sostek, M.D., F.A.C.G. and A.G.A.F., Executive Director, Clinical Research, AstraZeneca. “The findings from PN400-304 add to the body of data demonstrating that VIMOVO is an effective and generally well tolerated treatment option for osteoarthritis patients at risk of developing NSAID-associated gastric ulcers.1 In a single tablet, VIMOVO delivers both the proven pain relief of naproxen with the gastric ulcer risk reduction of esomeprazole in every dose of the medication.3

No new or unexpected safety issues emerged throughout the treatment period.1 Among all patients in the study (N=239), the most common adverse events were dyspepsia (7.9%), constipation (5.9%), and nausea (5.0%).1 Among the 12-month population (N=135) that completed the trial, the most common adverse events were upper respiratory tract infection (URTI) (9.6%), dyspepsia (5.9%), back pain (5.2%), and contusion (5.2%).1 In addition, laboratory tests, vital signs, physical examination, and ECG assessments showed no new or unexpected findings.1

PN400-304 was an open-label, multicenter, Phase 3 study designed to evaluate the long-term safety of VIMOVO. 1 The study included H. Pylori-negative patients ages 18 and older with OA, RA, AS, or other conditions requiring daily NSAID therapy, who were at risk for NSAID-associated gastric ulcers either due to age (at least 50 years) or history of ulcer in the past five years. 1 Patients were treated with VIMOVO twice daily for 12 months.1

VIMOVO, which was approved by the FDA in April 2010, is available in pharmacies across the country. Patients and physicians can find out about VIMOVO formulary access by visiting www.yourformularyinfo.com. Physicians can also learn more about VIMOVO by visiting www.VIMOVOtouchpoints.com, an interactive forum where they can chat with a Personal Account Specialist, find health plan coverage information in your area, and easily access information about the efficacy, tolerability and safety profile of VIMOVO, and access and affordability. In addition, the e-sampling feature on the Web site allows physicians to order samples of VIMOVO at their own convenience.

Important Safety Information

 

  • Like all medications that contain nonsteroidal anti-inflammatory drugs (NSAIDs), VIMOVO may increase the chance of a heart attack or stroke that can lead to death. This chance increases
    • With longer use of NSAID medicines
    • In people who have heart disease
  • NSAID-containing medications, such as VIMOVO, should never be used before or after a type of heart surgery called coronary artery bypass graft (CABG)
  • As with all medications that contain NSAIDs, VIMOVO may increase the chance of stomach and intestinal problems, such as bleeding or an ulcer, which can occur without warning and may cause death
    • Elderly patients are at greater risk for serious gastrointestinal events

VIMOVO is not right for everyone, including patients who have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine, patients who are allergic to any of the ingredients in VIMOVO, or women in late stages of pregnancy.

Serious allergic reactions, including skin reactions, can occur without warning and can be life-threatening; discontinue use of VIMOVO at the first appearance of a skin rash, or if you develop sudden wheezing; swelling of the lips, tongue or throat; fainting; or problems swallowing.

VIMOVO should be used at the lowest dose and for the shortest amount of time as directed by your health care provider.

Tell your health care provider right away if you develop signs of active bleeding from any source.

VIMOVO can lead to onset of new hypertension or worsening of existing high blood pressure, either of which may contribute to an increased risk of a heart attack or stroke.

Speak with your health care provider before starting VIMOVO if you

 

  • Have a history of ulcers or bleeding in the stomach or intestines
  • Have heart problems, high blood pressure, or are taking high blood pressure medications
  • Have kidney or liver problems

Review all the medications, even over-the-counter medications, you are taking with your health care provider before starting VIMOVO.

Talk to your health care provider about your risk for bone fractures if you take VIMOVO for a long period of time.

The most common side effects of VIMOVO include: inflammation of the lining of the stomach, indigestion, diarrhea, stomach ulcers, abdominal pain, and nausea.

Approved Uses for VIMOVO

VIMOVO is approved to relieve the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of stomach (gastric) ulcers in patients at risk of developing stomach ulcers from treatment with NSAIDs.

VIMOVO is not recommended as a starting treatment for relief of acute pain. Controlled studies do not extend beyond 6 months.

For further information on VIMOVO, please see the full Prescribing Information, including Boxed Warnings, at http://www1.astrazeneca-us.com/pi/vimovo.pdf and www.VIMOVOtouchpoints.com or by calling 1-866-272-0402, Monday through Friday between the hours of 8:30 AM and 8:30 PM ET, excluding holidays.

NOTES TO EDITORS

About VIMOVO

VIMOVO is a fixed-dose combination of delayed-release enteric-coated naproxen, a non-steroidal anti-inflammatory drug (NSAID), and immediate-release esomeprazole, a stomach acid-reducing proton pump inhibitor (PPI), approved for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers. 3 VIMOVO is not recommended for use in children younger than 18 years of age. 3 VIMOVO is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. Controlled studies do not extend beyond 6 months.3

VIMOVO has been developed as a sequential-delivery tablet formulation combining an immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core. As a result, esomeprazole is released first in the stomach, prior to the dissolution of naproxen in the small intestine. The enteric coating prevents naproxen release at pH levels below 5.5.3

About Osteoarthritis

Osteoarthritis is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints.6 Osteoarthritis is the most common form of arthritis, affecting 151 million individuals worldwide7 and 27 million Americans4. A combination of factors can contribute to osteoarthritis, including being overweight, aging, joint injury or stress, heredity, and muscle weakness8. Osteoarthritis commonly affects the hands, spine or large weight-bearing joints, such as the hips and knees.7

About Rheumatoid Arthritis

Rheumatoid arthritis is a chronic disease, mainly characterized by inflammation of the lining, or synovium, of the joints. It can lead to long-term joint damage, resulting in chronic pain, loss of function, and disability.9

About Ankylosing Spondylitis

Ankylosing spondylitis is a chronic inflammatory disease that primarily causes pain and inflammation of the joints between the vertebrae of the spine and the joints between the spine and pelvis (sacroiliac joints). Ankylosing spondylitis may also cause inflammation and pain in other parts of the body as well.10

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

1 Sostek, et al; Evaluation of the Long-term Safety of a Fixed-Dose Combination of Naproxen and Esomeprazole Magnesium in Patients Requiring Chronic Nonsteroidal Anti-inflammatory Drug (NSAID) Therapy: Results from a 12-Month Multicenter Safety Study.

2 Current Medical Research & Opinion-Vol. 27, No. 4, 2011, 847–854.

3 American College of Gastroenterology. (ACG) Ulcer Physician Reference Guide. http://www.acg.gi.org/patients/pdfs/ACGUlcerPhysRefGuide.pdf Accessed April 2009.

4 Prescribing Information for VIMOVO. AstraZeneca Pharmaceuticals LP, Wilmington, DE.

5 Helmick, C., Felson, D., Lawrence, R., Gabriel, S., et al. Estimates of the Prevalence of Arthritis and Other Rheumatic conditions in the United States. Arthritis & Rheumatism 58(1), 15-25. 2008.

6 Arthritis Foundation. Osteoarthritis: What is it? http://www.arthritis.org/disease-center.php?disease_id=32 Accessed April 16, 2010.

7 Global Burden of Osteoarthritis in the year 2000, (Symmons, Mathers, Pfleger, 2006), Global Burden of Disease 2004.

8 American College of Rheumatology. Osteoarthritis. http://www.rheumatology.org/public/factsheets/diseases_and_conditions/osteoarthritis.asp. Accessed February 23, 2009.

9 Mayo Clinic. Rheumatoid Arthritis. Definition. http://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020. Accessed October 2009.

10 Mayo Clinic. Ankylosing Spondylitis. Definition. http://www.mayoclinic.com/health/ankylosing-spondylitis/DS00483. Accessed September 2009.

Contact: AstraZeneca
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Posted: March 2011

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