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The DUEXIS® Pivotal Clinical Trials1

The efficacy and safety of DUEXIS were evaluated in two phase 3 pivotal
clinical trials

  • The new drug application for DUEXIS was based in part on the results of two phase 3 pivotal
    clinical trials: REDUCE-1 (Study 303) and REDUCE-2 (Study 301)
    • Randomized, double-blind, comparator-controlled, multicenter trials that enrolled patients
      with mild-to-moderate pain
The efficacy and safety of DUEXIS were evaluated in two phase 3 pivotal clinical trials

*The clinical trials primarily enrolled patients aged < 65 years (median age 55 years) without a history of GI ulcer. Endoscopic examinations at baseline and weeks 8, 16 and 24. Controlled trials did not extend beyond 6 months.

†Including 776 patients with osteoarthritis and 54 patients with rheumatoid arthritis.2

‡At week 24 or at early termination.


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The DUEXIS® Pivotal Clinical Trials1

Patient selection:

  • Patients were expected to require daily NSAID treatment for more than 6 months for conditions such as osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome and chronic soft tissue pain*
  • Patients were randomized 2:1 for treatment with DUEXIS (800 mg ibuprofen/26.6 mg famotidine) or 800 mg ibuprofen orally TID
  • Inclusion/exclusion criteria included:
    • Patients aged 39 to 80 years (Clinical trials primarily enrolled patients <65 years of age without a prior history of GI ulcer. Controlled trials did not extend beyond 6 months.)
    • No NSAID use for 30 days prior to study entry
  • REDUCE-1 and REDUCE-2 enrolled 1022 patients randomized to treatment with DUEXIS and 511 patients treated with ibuprofen alone

The adverse events observed for DUEXIS are consistent with the known safety profiles of ibuprofen and famotidine

*DUEXIS is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers.

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DUEXIS® Results

DUEXIS reduced the risk of ibuprofen-induced upper GI ulcers by ~50% in
two 24-week multicenter trials1

DUEXIS reduced the risk of ibuprofen-induced upper GI ulcers by ~50% in two 24-week multicenter trials
  • Patients taking DUEXIS reported significantly less dyspepsia as an adverse reaction than did patients taking ibuprofen alone (5% vs 8%, respectively, P=0.0086)1,2

*This analysis excludes patients who dropped out of the study prior to the first endoscopy (at 8 weeks); patients who dropped out of the study without an endoscopic evaluation within 14 days of their last dose of study drug were classified as not having an ulcer.

†In REDUCE-1 (Study 303), the secondary endpoint was incidence of upper GI ulcers.

‡In REDUCE-2 (Study 301), the primary endpoint was incidence of upper GI ulcers.

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DUEXIS® Results

DUEXIS provided consistent reduction of upper GI ulcers over 24 weeks

DUEXIS provided consistent reduction of upper GI ulcers over 24 weeks

*Number of patients at baseline.

 


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DUEXIS® Results

DUEXIS provided consistent reduction of upper GI ulcers in patients using low-dose aspirin1

In a subgroup analysis:
  • There was a 54% reduction in incidence of upper GI ulcers in patients who used low-dose aspirin and received DUEXIS compared with patients who used low-dose aspirin and received ibuprofen only (16% vs 35%, P=0.0071)1,2
DUEXIS provided consistent reduction of upper GI ulcers in patients using low-dose aspirin

As with other NSAIDs, the use of aspirin and DUEXIS may increase the risk of adverse events, including GI bleeding

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WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

See full Prescribing Information for complete boxed warning.

  • Ibuprofen, a component of DUEXIS, may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.
  • NSAIDs, including ibuprofen, a component of DUEXIS, increase the risk of serious gastrointestinal (GI) adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.

Important Safety Information About DUEXIS

  • DUEXIS should not be given to patients who have experienced asthma, urticaria, or allergic reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylaxis with NSAIDs has been reported in such patients. DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery. DUEXIS is contraindicated in patients in late stages of pregnancy as premature closure of the ductus arteriosus in the fetus may occur. DUEXIS should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists. Cross sensitivity with other H2-receptor antagonists has been observed
  • When active and clinically significant bleeding from any source occurs in patients receiving DUEXIS, the treatment should be withdrawn
  • NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events. Monitor blood pressure closely during treatment with DUEXIS.
  • Fluid retention and edema have been observed in some patients taking NSAIDs. DUEXIS should be used with caution in patients with fluid retention or heart failure
  • Long-term administration of NSAIDs, including ibuprofen, which is a component of DUEXIS tablets, has resulted in renal papillary necrosis and other renal injury. Use DUEXIS with caution in patients at risk (eg, the elderly; those with renal impairment, heart failure, or liver impairment; and those taking diuretics or ACE inhibitors)
  • Hepatic injury ranging from transaminase elevations to liver failure can occur. If clinical signs and symptoms consistent with liver disease develop, if abnormal liver tests persist or worsen, or if systemic manifestations occur, DUEXIS should be discontinued immediately
  • Anaphylaxis may occur in patients with the aspirin triad or in patients without prior exposure to DUEXIS. If an anaphylactoid reaction occurs, DUEXIS should be discontinued immediately
  • Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal, can occur. Discontinue DUEXIS if rash or other signs of local skin reaction occur
  • Nursing mothers should use DUEXIS with caution, as it is not known if ibuprofen is excreted in human milk, and famotidine is excreted in human milk
  • The most common adverse reactions (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain, and headache
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Please see Medication Guide and full Prescribing Information on this Web site.

 

Indication for DUEXIS

DUEXIS, a combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.

References
  1. Duexis (package insert). Hunt Valley, MD: Pharmaceutics International, Inc. 2011.
  2. Data on file. Horizon Pharma.
  3. Weinblatt ME, Genovese, MC. Klivitz AJ, et al. Efficacy, safety and tolerability of HZT-501, including users of low-dose aspirin, a single-tablet combination of ibuprofenfamotidine: results of two phase 3 trials (abstract). Arthritis Rheum. 2010:62(suppl 10):945.

This product information is intended for US Health Care Professionals and Consumers only.
© 2011 Horizon Pharma. All rights reserved. 0043DUEX02
DUEXIS is a registered trademark of Horizon Pharma