Prexige data not fat enough for USA

[injuryupdate]

The new COX-2 inhibitor NSAID Prexige is now available in Australia, New Zealand and quite a few other countries around the world, but not the USA. The USA FDA has much more stringent pre-release data required after the Vioxx fiasco. Prexige has apparently passed all of the hurdles with respect to safety. However, its efficacy has only been tested in a European population and the FDA apparently won't let in on to the US market until it is tested on Americans, because - apparently - the European women aren't fat enough to be considered representative of the US population.

Maybe McDonald's does the same thing when they are testing their hamburgers.

[injuryupdate]

Just heard that Mobic is now leading COX-2 in Australia.

Will be interesting to see how long the Feds keep Celebrex on the PBS (when they are also blasting it on the packet as being unsafe for the heart) compared to Prexige which doesn't have the same problem with the studies to date.

[injuryupdate]

Got some feedback on Prexige last week at a dinner they put on. One of the NRL docs mentioned that his players rate the drug so highly that his players are actually prepared to go out and PAY for a prescription of it (approx $16 for 5 tabs of 1/day). Anyone who knows of the legendary tightness of professional football players will appreciate this is impressive news!

Still for the general population Novartis have an uphill battle until they get PBS listing.