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FDA accepts Horizon Pharma, Inc.’s New Drug Application for arthritis medication
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Horizon Pharma, Inc., announced that its New Drug Application (NDA) for Duexa, a proprietary tablet formulation containing a fixed-dose combination of ibuprofen and high-dose famotidine, was accepted by the U.S. Food and Drug Administration for review, according to a press release.
Horizon said it is seeking FDA approval of Duexa for the reduction of the risk of development of upper gastrointestinal (GI) ulcers in patients with arthritis and pain. The Prescription Drug User Fee Act (PDUFA) date for completion of the FDA’s review for Duexa is expected in the first quarter of 2011.
“As the pain and arthritis market continues to grow, safe and effective treatments are desperately needed for physicians and patients concerned about the gastrointestinal impact of NSAIDs,” Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma, stated in the press release. “We look forward to working closely with the FDA to bring Duexa to market as quickly as possible. The filing of the Duexa NDA brings us one step closer to providing the millions suffering from mild-to-moderate pain and arthritis with a new treatment option.”
The Duexa NDA 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 GI ulcers compared to patients treated with ibuprofen alone, the company stated. The trials were conducted in the United States via a Special Protocol Assessment (SPA) with the FDA and enrolled more than 1,500 patients. Based on these data, the company also plans to submit a Marketing Authorization Application for the drug in the European Union through the Decentralized Procedure in the second half of 2010.