Anybody Take This Medication

Prexige (Lumiracoxib) Cleared for Approval in the European Union as a New Treatment Option for Patients Suffering From Osteoarthritic Pain
Prexige offers patients effective osteoarthritic pain relief with significantly fewer serious gastrointestinal problems than NSAIDs[1]

Prexige the best-studied NSAID - pre-launch trial data from 34,000 patients offer largest-ever body of evidence to support the launch of an anti-inflammatory agent

Novartis committed to supporting healthcare professionals with appropriate guidance for patient selection and product use

BASEL, SWITZERLAND -- November 7, 2006 -- Novartis announced today that Prexige (lumiracoxib), an oral selective COX-2 inhibitor anti-inflammatory drug, has been cleared for approval in the European Union as a new treatment option for patients suffering from osteoarthritis. This is the most common form of arthritis and a leading cause of chronic pain[2].

Prexige has successfully completed the Mutual Recognition Procedure (MRP) in the European Union, and all 26 EU member states have agreed to issue national approval. Initial approval for Prexige was granted in the United Kingdom, where it has been available since December 2005.

In addition to the EU, Prexige is already approved in more than 25 countries, including the approval also today in Canada. It is expected to become available in European countries during 2007 and 2008. Novartis plans to resubmit Prexige for US approval in 2007.

Prexige will be available in 100 mg tablets (once daily dosing) and indicated for the symptomatic relief in the treatment of knee and hip osteoarthritis. The decision was based on data from clinical trials involving 34,000 patients - the largest-ever body of evidence supporting the launch of an anti-inflammatory agent.

Prexige differs from other selective COX-2 inhibitors by targeting the site of pain, rapidly clearing from the blood and being quickly absorbed in the inflamed joint[3]. Prexige offers similar pain relief to the commonly used osteoarthritis medication celecoxib[4],[5], [6], [7]. However it has demonstrated a superior gastrointestinal safety profile to traditional non-steroidal anti-inflammatory drugs (NSAIDs)[1].

"Many patients cannot tolerate the gastrointestinal side effects associated with NSAID pain treatments. In addition, not all osteoarthritis patients respond to currently available pain medications," said Dr. Gerd Burmester, Professor of Medicine at the Humboldt University in Berlin, Germany, and one of the leading investigators of the TARGET study. "Lumiracoxib has been extensively studied for both efficacy and safety and has the potential to provide a valuable new treatment option for physicians."

Gastrointestinal safety concerns for patients using NSAIDs are much more serious than an upset stomach or heartburn. Up to 16,500 people in the US[8] and 2,500 in the UK[9] die each year as a result of severe bleeding ulcers in the stomach and intestine, which usually occur without warning[10].

The TARGET study, the largest published one-year study of gastrointestinal safety outcomes in osteoarthritis patients to date (n=18,325), has demonstrated that Prexige significantly reduced the incidence of serious upper GI complications by 79% compared with the NSAIDs ibuprofen and naproxen in patients not taking aspirin[1]. In further sub-analyses, Prexige reduced the risk of ulcer complications within the first month of use[11] and offered significant benefit compared to naproxen in older patients at greater gastrointestinal risk[12].

Furthermore, compared to NSAIDs, Prexige demonstrated a similar cardiovascular safety profile and a significantly smaller effect on blood pressure[13], [14].

"Novartis has worked closely with the health authorities to ensure a full review of all Prexige efficacy and safety data, especially the cardiovascular data, to confirm the benefit for patients," said James Shannon, MD, Global Head of Development for Novartis Pharma AG. "We are delighted that Prexige will soon be available to patients in Europe, and we are committed to providing physicians with the information they need to appropriately prescribe and select patients for Prexige."

Health authorities, including the European Medicines Agency and the US Food and Drug Administration (FDA), have concluded that the benefit/risk ratio for NSAIDs and selective COX-2 inhibitors remains positive when used in their target patient populations. Both Novartis and the health authorities agree that anti-inflammatory treatments should be used at the lowest possible dose for the shortest possible duration
Maybe try a chronic pain forum.
Drugfree

Havent heard of it but I was interested to hear there is another Cox-2 inhibitor type of meds available for arthritis pain down the road that is non narcotic..

Sorry Lisa but I know there are a number of people here that do have pain issues so IMO the information given was appreciated..

hugs,

Ali
I was telling him to try a chronic pain board and maybe they would know there....
Ali after 10,000 and 2 yrs she just does not get it.

Only cause It was me she feels the need anger?

Ali Stacy posts a great question about anger Lisa?

Her Response? Pretty judgemental if you ask me. But hey just an observation????

I posrted it on the bottom You decide--Its sad.

But I do not care what anyone thinks of me. And I was going to leave Ali as It was gertting to me. But someone I respect highly told me NO dont leave. Anyway

I post to help. Some see it some just dont?

And if every time I post Lisa wants to give me advice well ?" If it does not apply let it fly"

Ali try and Janet and Pam and Molly and all of us pain sufferers

try---------- www.weeklyedition@docguide.com

Ali I am sorry. If your able to get on this you will see how many different subjects it handles.

I have to clean out my e-mails and after sending this one I cleaned them all out. The last one was not worthy of posting. I will trey to find an old one.

You probably can go back in there history its amazing stuff. I am in contact with some people trying to find out the difference. And Can I cause of my overuse of Tylenol and bextra ever use these new cox2 meds??

Its funny but the ignorance of some people amaze me. And I am not attacking anybody. I tried once to help this person. But WTF do i know?? I am an IDIOT a Putz give bad advice. I am a bad mean person. BOOOo-LOL

Its really comical-that someone would tell me to take my information to another board--a Pain Board? How many people here are dying for a replacement of bextra or Vioxx

Sheet they sold BILLIONS a year wash Rush Limbaugh taking them all??

How many people knew about OPANA that's the crap Lisa you get on a pain board. They push the newest Oxycontin.

Ali I pray this helps Let me know.--Jeff




Posts: 10888
Joined: February 12, 2004



Thank you for posting that Stacey. I need a reminder about my own anger and I think a few others could learn from this as well.

--------------------


When you judge another, you do not define them, you define yourself




Whatever Jeff....I'm not going to defend myself anymore to you,. You just don't get it, do you?

You want answers about chronic pain and chronic pain medicine, you go to a chronic pain board. That's all I was trying to say.

Maybe you should try re-reading Stacy's post about anger for clarity.

Peace
Lisa...with all due respect I think that it is obvious that you have a strong dislike for Jeff...for whatever reason...it shines through clearly on anything you post to him. So perhaps you should just stay away from his posts and threads...I find that is the best way to work out these types of problems....he can play in his sandbox and you can play in yours!!

When you came here looking for information on Paxil....Jeff or anyone else for that matter didn't tell you to go find a depression information board!!

Chronic pain effects many here...very very many...in fact that is how alot of us got started!

Lets just try to be nice...or not be at all.....not all personality are gonna mesh here all the time...but everyone has a right to an opinion.

Thats all...
While I respect your opinion KeeKee, it would be nice if mine was respected as well.

It seems as though everyone else is welcome to thiers, but when I voice mine, there's an uproar. Why? Because I said it. Someone else can say the exact same thing and no one gives it another thought.

I do like Jeff. So you're wrong there.

Have a nice night.
Lisa...I don't know what you are talking about...I think there are alot here that respect your opinion....but not everyone will..so what...thats life!

And opinions are like bums...everyone has one!

I certainly don't expect everyone to "get" my opinions....thats what makes it a big wide world.

I mean no disrespect...I am merely pointing out that you do seem to aggressively go after anything Jeff say....just an observation.


I will have a nice evening...still afternoon here...we will hit the beach for a few hours before we loose daylight! Have a good one

edited to say - I know Jeff can fight his own battles...I just notice this alot and thought I would comment
I knew what you meant KeeKee and I get it...just remember that I'm allowed that opinion as well so when I say go to a chronic pain board to look for info on meds, it was just an opinion. Last time I checked this was a recovery board and we are trying to NOT take meds. Doesn't mean people can't talk about it, just means you're not always going to find the info your looking for.

Jeff can be pushy when it comes to meds, so my coming in behind him is to make sure that people know they don't have to take medicine in order to be happy. Has nothing to do with him as a person. I'm sure he's very nice.

Enjoy the beach! Snowing like a bugger here. We're going to try for Kona in January...I can't wait.

Lisa
I have no dislike for anybody. I am a human being I make mistakes. All the time.

But I come to this board to help people. Sadly I know way to much.

This is the one promise I was told I must do. Help my fellow addict.

I dont care if people think I am Nuts. i am 100% Honest Nuts.

Jeff
I miss the snow....who said that???!!!

I think it is the time of year..Christmas decorations everywhere...Christmas music everywhere...just one thing missing!! The snow...I never in a million years expected to feel like this!!

It will be neat to experience Christmas here and I am sure I will get over it!!

If you come here you I would love to have coffee....that would be fun!
Nothing would make me happier than to sit and have a cup of coffee with you. There's nothing better than meeting someone face to face. I'll let you know if it works out. We are suppose to go to Cabo but neither of us want to go now. Would much rather go to Kona, it'll just depend on condo availablity.

We don't usually get snow this time of year, so this is a treat. It's so beautiful. Everything looks so clean. But I'll take that sand over snow any day...lol

Talk soon.
Lisa..that would be awesome..keep me posted!!1
Lisa

i think that the simplicity of your statement to Jeff could easily be misconstrued as being bitchy, and therein lies the problem of typing words on here without the ability to show facial expression, tone and demeanor...it happens time and time again and feelings can so easily be hurt..

The way you explained it sounds perfectly normal...even helpful..you thought Jeff should ADD this info to a chronic pain site, but it sounded like you were saying he shouldn't be posting it here...

If i misunderstood your post Lisa, i apologize, but if you read back at what you wrote perhaps you can see how it could misconstrued....we all should read our posts once or twice before we hit that post button, to see if it comes across the way we mean it to, but of course thats not always what we do...

Hugs

Ali
Hi Ali...how's it going up there? I hope your keeping warm...nice to see you around!
It wouldn't matter Ali.
Hey KEE KEE!!

Just posted to you on your other post...

Lisa,

YGM...sorry, didnt mean to stir anything up...

You didn't darlin. On my way to check now.