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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

--Data from Phase 3 REDUCE-1 and REDUCE-2 Studies Demonstrate that Novel Combination Treatment Decreases Risk of Developing GI Ulcers by Approximately 50 Percent--

--Data presented today at 56th Annual Digestive Disease Week Meeting in Chicago--

CHICAGO, June 1 /PRNewswire/ -- Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today presented data at the 56th Annual Digestive Disease Week (DDW) meeting from two pivotal Phase 3 trials evaluating its lead compound HZT-501, which demonstrated that patients with mild-to-moderate pain treated with HZT-501 developed 50 percent less NSAID-induced upper gastrointestinal (GI) ulcers (gastric and/or duodenal ulcers) compared to patients treated with ibuprofen alone. HZT-501 is a novel, proprietary fixed-dose combination tablet containing the most prescribed non-steroidal anti-inflammatory drug (NSAID), ibuprofen, and famotidine, the most potent H2 antagonist.

"NSAIDs, such as ibuprofen, are among the most widely used drugs in the world," said Loren Laine, MD, professor of medicine, University of Southern California. "NSAIDs are effective at treating pain, but they also increase the risk of developing ulcers in the stomach or intestine and the risk of developing ulcer complications, such as bleeding. Patients at increased risk for gastrointestinal ulcers may benefit from protective co- therapy, although many such patients do not receive or adhere to this co-therapy."

The presentation at DDW included data from more than 1,300 evaluable patients who participated in the Registration Endoscopic Study to Determine Ulcer Formation of HZT-501 Compared to Ibuprofen: Efficacy and Safety Study, or REDUCE-1 and REDUCE-2. The primary objective of these studies was to evaluate the proportion of patients treated with HZT-501 (800 mg ibuprofen a
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SOURCE Horizon Therapeutics, Inc.
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