US-approved pain drug reduces ulcer risk

The FDA has approved Horizon Pharma’s Duexis, a new treatment for osteoarthritis and rheumatoid arthritis patients who are at risk for upper gastrointestinal ulcers.

The treatment contains a fixed-dose combination of ibuprofen and famotidine and has been proven to cause fewer upper gastrointestinal ulcers compared to ibuprofen alone.

Timothy P. Walbert, Chairman, President and CEO of Horizon Pharma, commented: “The approval of Duexis is a transformative event for Horizon Pharma, representing our first US approval. We would like to thank the patients and clinical investigators who participated in the pivotal REDUCE-1 and REDUCE-2 trials.”

The REDUCE-1 and REDUCE-2 trials studied more than 1,500 patients with mild-to-moderate pain or arthritis. In REDUCE-1, just 8.7% of patients treated with Duexis developed a gastric ulcer, compared to 17.6% of those who received ibuprofen alone. The comparison was 10.5% versus 20.0% in REDUCE-2, also in Duexis’ favour.

Michael Schiff, MD, Clinical Professor of Medicine at the University of Colorado School of Medicine, Rheumatology Division, said: “In my view, Duexis will allow more people access to the benefits of ibuprofen, while reducing the significant GI risk associated with its use.”

Horizon Pharma is a biopharmaceutical company focused on developing medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases.