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Horizon Pharma, Inc. Announces FDA Acceptance of DUEXA(R) New Drug Application for Filing
Date:5/26/2010

ication (MAA) for DUEXA in the European Union through the Decentralized Procedure in the second half of 2010.

About DUEXA

DUEXA is a novel, proprietary fixed-dose tablet combining the one of the world's most prescribed NSAIDs, ibuprofen, with a high dose of the most potent H2 antagonist, famotidine, in a single pill.  Ibuprofen has proven anti-inflammatory and analgesic properties, whereas famotidine reduces the stomach acid secretion that can cause gastric and duodenal ulceration.   By combining ibuprofen and famotidine into a single product, it is believed that ibuprofen's gastrointestinal safety profile will be improved without altering its ability to reduce pain and inflammation.

About the Arthritis and Pain Market

According to the Arthritis Foundation, arthritis affects 46 million people in the U.S. and costs the U.S. economy $128 billion annually.  According to a study by the Centers for Disease Control and Prevention (CDC) for the National Arthritis Data Workgroup, due to the increasing aging population, arthritis is projected to increase by 40 percent in the next two decades.  The CDC estimates that 67 million people in the U.S. will be affected by arthritis by 2030.  Additionally, chronic pain affects an estimated 86 million American adults. NSAIDs are among the most widely used drugs in the world for the treatment of arthritis and pain and are a major cause of GI complications, including ulcers. NSAIDs block enzymes and reduce prostaglandins throughout the body and as a consequence, ongoing inflammation, pain, and fever are reduced.  Because the prostaglandins that protect the stomach are reduced, NSAIDs often cause ulcers in the stomach. NSAID-induced GI toxicity causes an estimated 16,500 deaths and more than 107,000 hospitalizations annually in the U
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SOURCE Horizon Pharma, Inc.
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