Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today announced that two pivotal Phase 3 trials evaluating its lead investigational product candidate, HZT 501, met all primary endpoints. HZT 501, a novel, proprietary fixed-dose combination product containing ibuprofen and famotidine, demonstrated a statistically significant reduction in the incidence of non-steroidal anti-inflammatory drug (NSAID)-induced upper gastrointestinal (gastric and/or duodenal) ulcers in patients with mild-to-moderate pain when compared to ibuprofen alone.
NSAIDs such as ibuprofen are among the most widely used drugs in the world. However, NSAIDs are associated with a range of adverse side effects, which primarily affect the gastrointestinal (GI) tract. Up to 30 percent of patients taking NSAIDs experience gastrointestinal ulcers and a greater percent suffer from upper GI symptoms (i.e., dyspepsia, heartburn).
"NSAIDs, while highly effective in treating pain and inflammation, often lead to serious safety concerns, including significant gastrointestinal damage," said Timothy P. Walbert, president and chief executive officer, Horizon Therapeutics. "We are committed to bringing this much needed treatment to physicians and patients as quickly as possible and plan on submitting these strong HZT 501 Phase 3 results to U.S. and European regulatory authorities in 2009."
REDUCE-1 and REDUCE-2 Trial Design and Results
The Registration Endoscopic Study to Determine Ulcer Formation of HZT 501 Compared to Ibuprofen: Efficacy and Safety Study (REDUCE 1 and REDUCE 2) were two randomized, double-blind, controlled trials that enrolled more than 1,500 patients in the United States. The primary efficacy objective of REDUCE-1 was to evaluate HZT 501 in reducing the proportion of patients who develop endoscopically diagnosed gastric ulcers during the 24-week treatment period, as compared to ibuprofen, in patients at risk for NSAID-ind
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