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505(b)(2) Combination Meets Phase 3 Goals

Horizon Therapeutics announced yesterday that its “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.”  Note that the drug development program contained two Phase 3 trials, one examining gastric ulcers only, the other examining gastric and/or duodenal ulcers.

There are a number of development programs trying to find solutions to NSAID-induced ulcers.  NSAIDs are very effective pain reducing agents.  People with osteoarthritis need to take NSAIDs for life.  Yet NSAIDs are known to cause gastric ulcers.  Products like Horizon’s attempt to change the acidic environment in the stomach, other products are being developed to modify the NSAID to avoid action in the stomach.  These pro-drugs release the NSAID latter in the intestine or in the blood stream. None are totally effective since circulating NSAID can cause ulcers.