Study: FDA Approval Sought for Prexige® for Arthritis

Applications for regulatory approval of the arthritis drug Prexige®, a new innovative investigational COX-2 selective inhibitor, have been filed in the United States and the European Union.

The applications are based on data from clinical studies testing Prexige in more than 13,000 patients with osteoarthritis, rheumatoid arthritis, acute pain and dysmennorrhea (painful menstruation).

Highlights from the studies presented earlier this year demonstrated that Prexige (lumiracoxib, COX189) had efficacy equal to the current European "gold standard", diclofenac, in the treatment of patients with arthritis and pain.

Additional data showed that its gastrointestinal safety profile was 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.

Clinical trial data shows Prexige, a COX-2 selective inhibitor, to be highly effective in the treatment of the symptoms of arthritis and pain, while demonstrating improvements in safety and tolerability, including gastrointestinal safety, beyond traditional non-steroidal, anti-inflammatory drugs (NSAIDs).

Prexige® is manufactured by Novartis AG.

Other sources: Novartis