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Xiaflex approved by FDA today
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02/11/2010 18:13
Mike S

not registered

02/11/2010 18:13
Mike S

not registered

Re: Xiaflex approved by FDA today

Susan,

One more voice to add to the legion of pro NA proponents. I am EXTREMELY adverse to all things medical (but do what I deem I absolutely have to). After watching my small finger contract to 45, then 60 degrees, then 90 degrees over some 5-10 years (no visible modules or chords - at least not that I noticed), I began researching my symptoms. Self-diagnosis ultimately led me to be fairly certain that I had DC. Further research led me to discover the NA alternative to open hand surgery. Still cautious, I went to a leading hand surgeon who instantly confirmed my diagnosis and recommended surgery. When I asked him about NA, he told me that he was aware of it but was not interested. Shortly thereafter, in November of 2006, I flew up from LA to SF to have Dr. Denkler perform NA. This turned out to be one of the best decisions I've ever made and best medical encounters I've ever experienced. In my case, the procedure took about 30 minutes and involved some intense (but short) pain (associated with the injections of the anesthetic rather than the snapping of the cord(s)). The procedure was performed on a Friday afternoon. I took a cab back to the airport (could easily have driven), and flew home the same evening. Zero (absolute zero) after procedure pain. Kept the hand elevated for a few days as instructed. Went back to work on Monday morning. At the doctor's recommendation, I did see a hand therapist for a few months, and took to wearing a night splint (still do - loosely fitted at this point). The NA reduced my contracture ("PIP" - which can be difficult) from 90+ to as little as 15 degrees. As far as I can determine, the NA is "holding up" 100% thus far (although I have now noticed what I believe to be some nodules).

In short (or long?), I would heartily recommend that you seriously consider NA if you have DC and associated contracture.

NA MAY have a slightly higher recurrence rate than traditional surgery but is SO MUCH less invasive, with FASTER recovery and (probably) less risk of complications. From what I've read so far, NA is also less painful, more effective, and less expensive than Xiaflex portends to be. NA tends to run about $700-800 (if one finger). Fortunately, my insurance covered it although I was of course out of pocket for airfare, tax fare, etc. WELL worth it!!!!

02/12/2010 01:42
Art

not registered

02/12/2010 01:42
Art

not registered

Re: Xiaflex approved by FDA today

Here's an article that states Xiaflex should have been compared to NA, not placebos and open surgery. It's written by a doc for investors interested in Auxilium.

http://www.kernsuslow.com/research/auxl_oct1508.pdf

02/12/2010 04:23
flojo 
02/12/2010 04:23
flojo 
Re: Xiaflex approved by FDA today

Lori, Luba, Randy and others who think NA is the thing to try first, I wholeheartedly agree!

Susan who has to make the decision, it is not an easy decision. I went through the same thing, "What should I do?" I had NA then RT. I'm still pleased with my decisions.

02/16/2010 19:09
Mike S

not registered

02/16/2010 19:09
Mike S

not registered

Re: Xiaflex approved by FDA today

Art,

Great report by the investors. Powerful. Clear. Hard-hitting Precise/spot-on.

02/16/2010 19:42
jimh 
02/16/2010 19:42
jimh 
Re: Xiaflex approved by FDA today

Very interesting investor analysis and whil I agree with most of it, I have 2 issues with the conclusions

1. The analysis refers to the "inability to convince physicians of equivalence or superiority to surgery". In general you'll have a hard time convincing a surgeon of the superiority of a non-surgical treatment. However, you'll have a lot less trouble convincing ME, a patient who's already had 2 surgeries. This report completely whitewashes a major downside of surgery - the extremely long, inconvenient and tedious recovery process. In the end, isn't it the patient who should decide which treatment is better?

2. The authors rate FDA approval only a 50% probability. Clearly they were wrong, and in fact I don't think there was ever much doubt. That tends to reduce their credibility somewhat.

In general though, I think they're right and in particular, it's clear that Auxilium is trying to price Xiaflex too high.

02/16/2010 20:11
Randy_H 
02/16/2010 20:11
Randy_H 

Re: Xiaflex approved by FDA today

The fact that NA showed up on the radar enough to be included in this report is a tribute to Eaton's efforts in his self appointed mission to bring NA into the mainstream. It also speaks highly of the author for not believing the uninformed dismissal of NA coming from the majority of American hand surgeons.

It's far too late for Auxilium to be intimidated by the success of NA. They missed that boat when they bought the patient from BioSpecifics and then forged ahead with the FDA. I think they drank the typical "hand surgeon cool aid" that this author avoided by stating "....does not accurately reflect how treatment with Xiaflex compares with existing, effective treatment modalities (Read NA)."

Now only time will tell who wins. Auxilium has everything to loose while Eaton has nothing. The only way we patients loose is if more "hand surgeon cool aid" causes the MD's to go Lemming on us and buy into Xiaflex enough to block the further spread of NA. On the other hand, an actual objective comparison between the too will have NA kicking Xiaflex right in the syringe. Therefore, at the price Auxilium may need to charge, Xiaflex and NA may not be able to co-exist. It may be that only one can survive. The battle between these mortal enemy is about to be joined.

Jimh: "I don't think there was ever much doubt <about Xiaflex's FDA approval>."

Really? I can't believe you actually said that. My memory is not that short! :-)

02/17/2010 03:06
flojo 
02/17/2010 03:06
flojo 
Re: Xiaflex approved by FDA today

Randy,
Isn't the key really to get to the GPs and other practitioners who refer for treatment? My doctor, physical therapist for other ailments and dermatologist have seen with their own eyes what NA did for me and know it was a cake walk as far as recovery.
I showed my podiatrist, who I saw for a toe nail problem, but I could tell she really wasn't interested, especially after I mentioned that there are alternative treatments for Ledderhose's.
I'm on a mission to let every possible doctor in my town know. Wish I knew how to reach groups of them.

02/17/2010 12:01
quest

not registered

02/17/2010 12:01
quest

not registered

Price of Xiaflex just announced.

$$3,250.00 per vial with the average patient to need 1.1 vial. Wonder if you can purchase 0.1 vial?


http://www.corporate-ir.net/seccapsule/s...6750061&dc=

02/17/2010 15:08
art

not registered

02/17/2010 15:08
art

not registered

Re: Xiaflex approved by FDA today

That is the wholesale cost, not retail which would be about a 25% markup, and that comes to a stunning $ 4,062.50 per vial. The average person is going to need two vials per CORD which brings it up to a whopping $8,125. I just don't see any insurance company paying that cost. Does anyone have that kind of money to spend without getting any money back? And what if you have multiple fingers/cords affected by Dupuytren's?

02/18/2010 01:06
jimh 
02/18/2010 01:06
jimh 
Re: Xiaflex approved by FDA today

It's never going to happen at that price.

Edited 02/18/10 04:22

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Pharmaceuticals   electro-mechanic   Auxilium   contracture   Dupuytren   progression   nodules   patients   information   procedure   practitioners   Xiaflex   surgery   orphan-designated   insurance   placebo-controlled   surgeon   treatment   approved   biopharmaceutical