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October 4, 2002
Highlights from key Phase II studies presented for the first time at EULAR, the European League Against Rheumatism annual congress, Stockholm, demonstrate that Prexige (lumiracoxib), a new investigational COX-2 selective inhibitor, has efficacy equal to the current European “gold standard”, diclofenac, in the treatment of patients with arthritis and pain.
Additional data presented at EULAR confirm Prexige is well tolerated, and its gastrointestinal safety profile is superior to non-steroidal anti-inflammatory drugs (NSAIDs) in this patient group. All results to date support the potential use of Prexige in the treatment of symptoms of arthritis and pain.
NSAIDs are commonly used for treating pain associated with arthritis. However, they are associated with gastrointestinal (GI) ulcers and bleeding, due to non-selective inhibition of cyclooxygenase (COX). The Phase II data with Prexige shows it to be highly effective in the treatment of the symptoms of arthritis and pain, while demonstrating improvements in safety and tolerability, including GI safety, beyond traditional NSAIDs.
Results of an exploratory analysis of a large multinational study of 583 patients confirm the clinical relevance of the findings previously presented by Schnitzer, et al. The assessment of the responder rate of Prexige in osteoarthritis (OA) pain show that Prexige at 400mg once daily is highly effective for the treatment of patients with OA. These findings suggest that Prexige provides the same strong efficacy as high doses of diclofenac (75mg twice a day) in treatment response defined as a 20% reduction in OA pain intensity based on the visual analog scale measure.
Commenting on the results, Jörg Reinhardt, Head of Development, Novartis Pharma AG, said: “These data suggest that Prexige is a highly efficacious COX-2 selective inhibitor. Prexige has been shown to be as efficacious as the “gold standard” treatment for arthritis, which is very encouraging news in the development of new treatments in this therapy area.”
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