FDA accepts NDA for Duexa for ulcer risk reduction in arthritis patients

Horizon Pharma announced that its New Drug Application (NDA) for Duexa was accepted by the FDA for the reduction of the risk of development of upper gastrointestinal ulcers in patients with arthritis and pain. This submission was based on two Phase 3 clinical studies (REDUCE-1 and REDUCE-2), which demonstrated that patients with mild-to-moderate pain treated with Duexa developed approximately 50% less upper gastrointestinal (GI) ulcers compared to patients treated with ibuprofen alone.

Duexa combines ibuprofen and famotidine into a single, fixed-dose tablet.  

For more information call (224) 383-3000 or visit www.horizonpharma.com.