HZT-501 (DUEXIS^®; ibuprofen 800 mg/famotidine 26.6 mg) gastrointestinal protection in the treatment of the signs and symptoms of rheumatoid arthritis and osteoarthritis

Abstract

Arthritis affects nearly 50 million people in the USA and, with the aging of the population, the prevalence is expected to rise. While NSAIDs are very effective in relieving pain associated with osteoarthritis (OA) and rheumatoid arthritis (RA), they are associated with side effects, including gastrointestinal (GI) toxicity, which may manifest as dyspepsia, ulcers and/or bleeding. A number of approaches have been employed in an effort to either completely avoid or reduce the risk of GI toxicities associated with NSAID use. Two new products combining an NSAID with a gastroprotective agent have recently been approved and other agents are in the pipeline. Patient adherence to prescribed gastroprotective therapy is known to be poor, often resulting in an increased risk of GI events in patients taking NSAIDs. These newer combination products may fulfill an important need for many patients who need to receive NSAIDs for the pain of OA and RA, but who are also at risk of upper GI events. This article reviews preclinical and clinical results for a new fixed-dose combination of ibuprofen and famotidine, DUEXIS^® (HZT-501), which has recently been approved in the USA for the relief of signs and symptoms of RA and OA and to decrease the risk of developing upper GI ulcers.

Keywords::

• famotidine
• gastrointestinal toxicity
• gastroprotection
• H2-receptor antagonist
• ibuprofen
• nonsteroidal anti-inflammatory drugs
• NSAIDs
• proton pump inhibitor
• ulcer

Financial & competing interests disclosure

M Schiff is a consultant for Horizon Pharma, Inc. D Peura is a consultant for AstraZeneca Pharmaceuticals, Horizon Pharma, Inc. and Takeda Pharmaceuticals, and a speaker for Otsuka and Takeda Pharmaceuticals. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors acknowledge Robert W Rhoades and Valorie J Thompson for providing editorial support. Compensation for editorial support was provided by Horizon Pharma, Inc.