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Horizon Therapeutics' HZT-501 Significantly Reduces Incidence of NSAID-Induced Upper Gastrointestinal Ulcers in Patients With Mild-to-Moderate Pain
Date:6/1/2009

the 24-week treatment period, as compared to ibuprofen, in patients at risk for NSAID-induced ulcers. The trials were conducted via a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA).

About HZT-501

HZT-501 is a novel, proprietary fixed-dose tablet combining the world's most prescribed NSAID, ibuprofen, with a high dose of the most potent H2 antagonist, famotidine, in a single pill. It is anticipated that HZT-501 will provide effective pain relief and reduce stomach acidity during the peak time of ulceration risk, thus reducing the risk of NSAID-induced ulcers.

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 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.S. alone.

If deaths from the gastrointestinal effects of NSAIDs were tabulated separately in the National Vital Statistics reports, these effects would equate to the 15th most common cause of death in the U.S. Studies h
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SOURCE Horizon Therapeutics, Inc.
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