The United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization to Horizon Pharma's Duexis (ibuprofen/famotidine) for the symptomatic treatment of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS)in patients who require regular treatment with high dose ibuprofen administered three times a day and who are at risk of developing non-steroidal anti-inflammatory drug (NSAID) associated gastric and/or duodenal ulcers.
Horizon is seeking to license rights to Duexis in Europe to one or more commercial partners.
"We are pleased that the UK health authority has granted marketing authorization, which we believe further validates Duexis as an important treatment option for patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis," said Todd N Smith, executive vice president, chief commercial officer, Horizon Pharma. "We are seeking a potential commercial partner or partners for Duexis in the UK and the rest of Europe. However, given the current state of the arthritis market in Europe and the revenue being generated there by existing branded NSAIDs, we expect the US market, where Duexis continues to gain traction, to continue to represent the most significant opportunity for Horizon."
Duexis, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated in the US 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 six months.
Osteoarthritis (OA) is a degenerative joint disease caused by the breakdown and eventual loss of the cartilage of one or more joints. It is the most common form of arthritis and the most common cause of chronic pain, affecting an estimated 27 million individuals in the US. OA is caused by various factors, including older age, being overweight, joint injury or stress, heredity and muscle weakness. OA commonly affects the hands, spine or large weight-bearing joints, such as the hips and knees.
Rheumatoid Arthritis (RA) is a chronic disease that causes pain, stiffness and swelling, primarily in the joints. RA occurs when the body's immune system malfunctions, attacking healthy tissue and causing inflammation, which leads to pain and swelling in the joints and may eventually cause permanent joint damage and painful disability.
Ankylosing spondylitis (AS) is a chronic, progressive, connective tissue disorder that is characterized by inflammation of the joints of the spine (vertebral joints), hipbones, and sacrum (sacroiliac joints). Symptoms of AS are similar to those of RA, including pain, swelling and stiffness in the affected joints.
Horizon Pharma, Inc. is a specialty pharmaceutical company that has developed and is commercializing Duexis and Rayos/Lodotra, both of which target unmet therapeutic needs in arthritis, pain and inflammatory diseases.