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Auxilium AA4500 Trials Report.
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03/19/2008 05:19
wach 

Administrator

03/19/2008 05:19
wach 

Administrator

Re: Auxilium AA4500 Trials Report.

Hi size15n: I love your description "In essence, meat tenderizer is being injected into the chord". That illustrates why they are cautious about the amount of injected collagenase. You wouldn't like to end up with a tenderized hand, would you? It is interesting that your skin surrounding the injection has changed. Do you think that's in transition or does it feel like a stable, permanent change? Any chance to describe how different it is?

Wolfgang

Quote:



I was in the Safety / Efficacy study of AA4500. I was told that I had extra thick chords. My chords did not snap until after the third injection. I was told that under the study I was limited to only three injections. As far as "disolving" the chords, that is what I was told occured by the doctor. In essence, meat tenderizer is being injected into the chord to weaken it. The tenderizer is given 24 hrs to do its thing and is then streched to "snap" the chord. If the chord is extra thick, additional treatments are necessary. There was a 30 day window between injections. Swelling and pain from the injection subsided within days of the injection. I believe that the 30 days was to allow surrounding tissue to recover from enzyme that 'leaks' from the chord. The skin surrounding the injection site definitely has changed. It seems 'different'. I am now about 120 days past the first injection. I am happy with the results. Hopefully the trials will be complete and it will be available locally by the time my other hand is bad enough to need treatment.


03/19/2008 11:24
size15n 
03/19/2008 11:24
size15n 
Re: Auxilium AA4500 Trials Report.

Hi Wolfgang,

When I say the skin is different, I mean that it seems more delicate. The skin seems "thinner". During the process of the injections and the weeks after the injections the area was very very tender. It was not so bad that I could not function but tender enough that I did not poke the area. Now that the injections are over, the tenderness is gone. The skin still looks a little thinner and slightly more wrinkled at the injection site. I expect that by the end of the summer no appreciable difference will be noticable. I hope this answers your questions.

Edited at 19.03.08 16:34

03/19/2008 13:06
wach 

Administrator

03/19/2008 13:06
wach 

Administrator

Re: Auxilium AA4500 Trials Report.

Sure does. Thank you!

Wolfgang

03/23/2008 00:36
kdenkler 
03/23/2008 00:36
kdenkler 
Info from Auxillium on the trials

Link on the trials from Auxillium:

http://xml.10kwizard.com/filing_raw.php?...k&ipage=5538795

03/24/2008 23:45
Randy_H 
03/24/2008 23:45
Randy_H 

False Advertising

Thanks Dr. Keith! As usual you bring us great information and links.

Auxilium's marketing *always* ignores NA's existance saying that there is "no other treatment" than OS. While I'm all in favor of Collegenase making it to market, that's blatant false advertising. They are also predicting that the average treatment cost will fetch about $5,000. If it were not for NA (at about $700) they could probably get that price. However, those of us in the know will not spend that kind of money unless NA can't be done for some reason and only Collegenase stands in the way of OS.

It will be interesting to see what NA's growing popularity will have on the final consumer's cost for Collegenase. It would need to provide *significantly* lower rates of recurrence to be worth anything near what they hope.

03/25/2008 18:42
jim_h 
03/25/2008 18:42
jim_h 
Re: Auxilium AA4500 Trials Report.

Auxilium's PR is aimed at investors and presents a rosy picture. When they start actually selling the product, insurance companies will decide how much they're willing to pay for it.



03/27/2008 16:14
JJN

not registered

03/27/2008 16:14
JJN

not registered

Re: Auxilium AA4500 Trials Report.

Collagenase recurrence data -

from the 1st phase III trial (early 2006) and the old phase 2 trial (2002), recurrence numbers look very promising.
8% at 24 months for the Phase 3 and ~5% at 4 years in the phase 2.

Also, Dr. Hurst said at the recent ortho society meeting that his patients from back in year 2000 showed about 8-10% recurrence at the MCP joint in 2 years.



Contrast this with the most recent article on recurrence rates in NA from 2006 which showed 65% at about 2.5 years.

well, it's a moot point anyways since there isn't a hand surgeon anywhere near me who i trust to be competent to do NA. from my understanding, the complication rates with surgeons who don't do NA very often are quite high.

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