DEERFIELD, IL -- (Marketwire) -- 03/07/13 -- Horizon Pharma, Inc. (NASDAQ: HZNP) today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for DUEXIS® (ibuprofen/famotidine) for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis 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 U.S. 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 U.S. 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 6 months. For more information, please visit www.DUEXIS.com.
Important safety information
Risk of Serious Cardiovascular and Gastrointestinal Events
See full Prescribing Information for complete boxed warning (according to the U.S. FDA approval)
Ibuprofen, a component of DUEXIS, may increase the risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. Risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
DUEXIS is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft surgery.
Nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen, a component of DUEXIS, increase the risk of serious gastrointestinal adverse reactions, including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. Reactions can occur at any time without warning symptoms. Elderly patients are at greater risk.
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