Novartis Painkiller Similar to VIOXX®

A clinical trial for Novartis AG's experimental painkiller Prexige® showed the risk of heart attack, stroke, and death was "similar" to Merck's now withdrawn Vioxx®, U.S. regulatory staff said in documents that were recently released.

Prexige®, which is not yet approved in the U.S., showed greater cardiovascular risk compared to naproxen but similar risks compared to ibuprofen, Food and Drug Administration staff said.

The trial documents were released ahead of the scheduled three-day meeting later this month when a FDA panel of outside experts will discuss Prexige®, Vioxx®, and other similar painkillers.

The FDA rejected Prexige® in 2003, stating that they wanted to see complete results of a two-part trial called Target.

One part of the Target trial, which followed about 18,000 patients for 52 weeks, showed 40 cardiovascular problems, including 11 deaths, in patients who took Prexige®.

FDA staff said those finding "are consistent with findings for Vioxx®," the painkiller that Merck & Co. pulled from the market last September after a study showed it raised the risk of heart attacks and strokes.

Novartis has said it may re-file for U.S. approval in 2007. Prexige® is approved in Britain and 20 other countries.

In other recent FDA documents, FDA staff questioned Merck’s newer painkiller called Arcoxia®, which they said showed "marginal" advantage over stomach problems but seemed to be worse than other painkillers regarding deaths and serious cardiovascular problems.

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