Horizon Therapeutics, Inc., a privately held biopharmaceutical company, today presented an analysis from two pivotal Phase 3 trials (REDUCE-1 and REDUCE-2) evaluating its lead investigational compound HZT-501, a combination of ibuprofen with high-dose famotidine. The analysis, which was designed to identify risk factors for the development of non-steroidal anti-inflammatory drug (NSAID)-associated ulcers, was presented at the 74th American College of Gastroenterology (ACG) Annual Scientific Meeting.
"Upper gastrointestinal tract ulcers develop commonly in people taking NSAIDs and can occur without warning symptoms. Historically there have been limited data identifying the factors that predict an increased risk of finding ulcers in NSAID users," said Loren Laine, MD, University of Southern California Keck School of Medicine and lead investigator. "Data collected from the REDUCE-1 and REDUCE-2 trials provide insight into these risk factors. The statistically significant independent risk factors included the use of the NSAID ibuprofen without the histamine-2 receptor antagonist famotidine, previous ulcer disease and older age."