The DUEXIS® (ibuprofen and famotidine) Tablets 800 mg/26.6 mg
Pivotal Clinical Trials1
The efficacy and safety of DUEXIS were evaluated in two phase 3 pivotal clinical trials.
The new drug application for DUEXIS (ibuprofen and famotidine) 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
- 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
*DUEXIS (ibuprofen and famotidine) is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing ibuprofen-induced upper GI ulcers.
The adverse events observed for DUEXIS are consistent with the known safety profiles of ibuprofen and famotidine.
*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.
DUEXIS reduced the risk of ibuprofen-induced upper GI ulcers by ~50% in two 24-week multicenter trials.1
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
- DUEXIS had fewer incidences of dyspepsia reported in controlled clinical trials compared with ibuprofen alone1
- The adverse events observed for DUEXIS are consistent with the known saftey profiles of ibuprofen and famotidine
*This analysis excludes patients who dropped out of the study prior to the first endoscopy (at 8 weeks).
†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.
§See Prescribing Information for alternative statistical analyses relating to such patients.
DUEXIS provided consistent reduction of upper GI ulcers over 24 weeks.
*Number of patients at baseline.
DUEXIS provided consistent reduction of upper GI ulcers in patients using low-dose aspirin.1
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
- With concomitant use of low-dose aspirin and ibuprofen, it is recommended that aspirin be taken at least 30 minutes before ibuprofen4
As with other NSAIDs, the use of aspirin and DUEXIS may increase the risk of adverse events, including GI bleeding.1
- DUEXIS (ibuprofen and famotidine) [package insert]. Hunt Valley, MD: Pharmaceutics International, Inc. 2012.
- Data on file. Horizon Pharma.
- Weinblatt ME, Genovese MC, Kivitz AJ, et al. Efficacy, safety and tolerability of HZT-501, including users of low-dose aspirin, a single-tablet combination of ibuprofen-famotidine: results of two phase 3 trials (abstract). Arthritis Rheum. 2010;62(suppl 10):945.
- Information for healthcare professionals: concomitant use of ibuprofen and aspirin. US Food and Drug Administration website. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm125222.htm. Updated September 29, 2010. Accessed August 9, 2011.