Another Cox-2 inhibitor is about to hit the market. In upcoming months, Novartis AG will begin selling Prexige, a Cox-2 inhibitor, across Europe, and they have also completed clinical drug trials to resubmit the drug for U.S. Food and Drug Administration (FDA) approval later this year. Novartis plans to have Prexige on the U.S. market by the first half of 2008.
Novartis first submitted Prexige for U.S. approval in 2002, but the FDA asked for additional safety and efficacy studies. The FDA had concerns about patients taking a 400-milligram dose of Prexige that showed signs of liver toxicity. The FDA was also concerned that Novartis had not sufficiently studied the drug in enough overweight people.
Novartis has since completed these trials and will submit the findings to the FDA. They are asking that the drug be approved for osteoarthritis treatment. Merck is also seeking FDA approval for their Cox-2 inhibitor, Arcoxia.
Cox-2 inhibitors were originally designed to be easier on the stomach than older pain relievers such as ibuprofen and naproxen. But Cox-2 drugs led to other serious problems. Vioxx was taken off the market after it increased the risk of heart attacks and strokes in patients, and Bextra was also removed for safety issues. Pfizer’s Celebrex is the only Cox-2 inhibitor available in the U.S. market currently.