Comments on: FDA Declines To Approve Novartis’ Prexige http://www.pharmalot.com/2007/09/fda-wont-approve-novartis-prexige-painkiller/ News, Comment and Conversation Fri, 10 Feb 2012 22:27:45 +0000 http://wordpress.org/?v=2.6.2 By: jason http://www.pharmalot.com/2007/09/fda-wont-approve-novartis-prexige-painkiller/#comment-21803 jason Wed, 10 Oct 2007 22:21:16 +0000 http://www.pharmalot.com/2007/09/fda-wont-approve-novartis-prexige-painkiller/#comment-21803 Reality, I completely agree with your comments. I wish someone would come up with an NSAID that has no adverse renal effects. To me that is more dangerous than the GI risk that can be mitigated with gastroprotection. Reality,

I completely agree with your comments. I wish someone would come up with an NSAID that has no adverse renal effects. To me that is more dangerous than the GI risk that can be mitigated with gastroprotection.

]]> By: Ramiro da Fonseca http://www.pharmalot.com/2007/09/fda-wont-approve-novartis-prexige-painkiller/#comment-21793 Ramiro da Fonseca Wed, 10 Oct 2007 20:56:54 +0000 http://www.pharmalot.com/2007/09/fda-wont-approve-novartis-prexige-painkiller/#comment-21793 So, what is really behind all this? It seems more like a financial war, where the patients are in second plan. In my oppinion Prexige should be out of the market for good. There will allwais remain some doubts, not only from the doctors, but also from the patients. Clearly Novartis was not abble to handle this problem So, what is really behind all this? It seems more like a financial war, where the patients are in second plan. In my oppinion Prexige should be out of the market for good. There will allwais remain some doubts, not only from the doctors, but also from the patients. Clearly Novartis was not abble to handle this problem

]]> By: Reality http://www.pharmalot.com/2007/09/fda-wont-approve-novartis-prexige-painkiller/#comment-20658 Reality Thu, 27 Sep 2007 12:14:10 +0000 http://www.pharmalot.com/2007/09/fda-wont-approve-novartis-prexige-painkiller/#comment-20658 Actually, I guess I'm somewhat surprised. The hepatic toxicity was only at the higher doses, and Prexige actually has a very good blood pressure profile as I recall, unlike some other COX-2s and NSAIDs, as well as a CV profile comparable to naproxen and better than ibuprofen. I think the issue here is that the FDA is spooked about this class, and doesn't want another Vioxx/VIGOR fiasco on its hands. There is a genuine need for these drugs in the right patient population -- those who require long-term analgesic treatment who can't tolerate traditional NSAIDs, which is not an insignificant number of people, and GI toxicity is not an insignificant outcome. Pfizer's got to be pretty happy about this -- they own the market (in the US). Actually, I guess I’m somewhat surprised. The hepatic toxicity was only at the higher doses, and Prexige actually has a very good blood pressure profile as I recall, unlike some other COX-2s and NSAIDs, as well as a CV profile comparable to naproxen and better than ibuprofen.

I think the issue here is that the FDA is spooked about this class, and doesn’t want another Vioxx/VIGOR fiasco on its hands.

There is a genuine need for these drugs in the right patient population — those who require long-term analgesic treatment who can’t tolerate traditional NSAIDs, which is not an insignificant number of people, and GI toxicity is not an insignificant outcome.

Pfizer’s got to be pretty happy about this — they own the market (in the US).

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