FDA approved tablet provides a new treatment option for RA sufferers who may be at risk for upper gastrointestinal ulcers stemming from chronic NSAID use.
Horizon Pharma, Inc., a biopharmaceutical company developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved DUEXIS® (ibuprofen/famotidine), a novel tablet formulation containing a fixed-dose combination of ibuprofen (800 mg) and famotidine (26.6 mg). The FDA approval was supported by data from the pivotal REDUCE-1 and REDUCE-2 studies, which showed patients taking DUEXIS experienced significantly fewer upper gastrointestinal ulcers compared to patients receiving ibuprofen alone.
"We look forward to providing DUEXIS to the many patients suffering from osteoarthritis and rheumatoid arthritis, as it provides a new treatment option for those who may be at risk for upper gastrointestinal ulcers stemming from chronic NSAID use," said Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma. "The approval of DUEXIS is a transformative event for Horizon Pharma, representing our first U.S. approval. We would like to thank the patients and clinical investigators who participated in the pivotal REDUCE-1 and REDUCE-2 trials."
DUEXIS was studied in more than 1,500 patients with mild-to-moderate pain or arthritis. The primary endpoint of the REDUCE-1 study was the reduction in incidence of gastric ulcers during the six month treatment period. The primary endpoint of the REDUCE-2 study was the reduction in incidence of upper gastrointestinal (defined as gastric and/or duodenal) ulcers during the six month treatment period. In REDUCE-1, DUEXIS demonstrated a statistically significant reduction in the incidence of gastric ulcers versus treatment with ibuprofen alone (8.7% versus 17.6%). In REDUCE-2, DUEXIS demonstrated a statistically significant reduction in the incidence of upper gastrointestinal ulcers versus treatment with ibuprofen alone (10.5% versus 20.0%).
The most common adverse reactions (≥1% and greater than ibuprofen alone) were nausea, diarrhea, constipation, upper abdominal pain and headache. Overall, the discontinuation rate in the REDUCE-1 and REDUCE-2 studies due to adverse events for patients receiving DUEXIS and ibuprofen alone were similar.
"The clinical data showed that DUEXIS helped reduce the incidence of upper gastrointestinal ulcers, which should be welcome news for physicians and patients concerned about the gastrointestinal impact of NSAID use," said Michael Schiff, M.D., Clinical Professor of Medicine at the University of Colorado School of Medicine, Rheumatology Division. "In my view, DUEXIS will allow more people access to the benefits of ibuprofen, while reducing the significant GI risk associated with its use."