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Horizon Therapeutics Announces Two Pivotal HZT-501 Phase 3 Trials Meet Primary Endpoints
Date:12/2/2008

riod, as compared to ibuprofen, in patients at risk for NSAID-induced ulcers. The primary objective of REDUCE-2 was to evaluate HZT-501 in reducing the proportion of patients who develop endoscopically diagnosed gastric and/or duodenal ulcers during 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).

Patients, who had mild-to-moderate pain, including those with osteoarthritis, were randomly assigned, in approximately a 2:1 ratio, to receive HZT-501 (800 mg ibuprofen and 26.6 mg famotidine) or ibuprofen (800 mg) alone orally three times daily for a 24- week treatment period or until patients developed either an endoscopically diagnosed upper gastrointestinal ulcer and/or prohibitive toxicity. Patients received endoscopies at baseline and weeks 8, 16 and 24. 8025 Lamon Avenue, Suite 110, Skokie, IL 60077

In REDUCE-1, 24-week treatment with HZT-501 resulted in a statistically significant reduction in gastric ulcers versus treatment with ibuprofen alone. In REDUCE-2, 24-week treatment with HZT-501 resulted in a statistically significant reduction in gastric and/or duodenal ulcers versus treatment with ibuprofen alone.

Treatment with both HZT-501 and ibuprofen alone were well tolerated in the studies. The majority were mild to moderate in severity. There were no significant differences between the two treatment groups adverse event or serious adverse event profiles.

"NSAIDs can cause significant gastrointestinal damage, including ulcers of the stomach and duodenum," said Loren Laine, MD, professor of medicine, Division of Gastrointestinal and Liver Diseases, Keck School of Medicine, University of Southern California. "These results indicate that HZT-501 can reduce the risk of ulcers, potentially improving the GI safety
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SOURCE Horizon Therapeutics, Inc.
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