Xiaflex

[LWillisjr]

I have one question that I read on a earlier forum, one man said the if you do not use the extender the curve comes back? was this with or with out the injection therapy?

Generally Peyronies hits goes through an acute stage and then stabilizes. Once you correct or improve the curvature (or other impact) then it shouldn't return. There are a few men on the forum who have had more than one occurrence or attack of Peyronies. So I don't believe your original curve will return. But nothing says that Peyronies won't hit more than once. But that is a different issue than the original curve coming back.

[MattFoley]

DO, can you please tell me your age? I need to know your age in order to put those numbers in proper perspective. Feel free to PM me if you prefer. Thank you.

[UK]

UK,

Have you had a full panel of blood work done telling you what your lipid and testosterone levels are? I urge you to do so if you haven't already. If you have, can you please tell me what they are? Thank you and God bless.

I had Testosterone checked out in relation to Peyronies and it was good for my age, don't have the figures however as they are with my GP. I put mine down to injury and being unlucky as I am sure others have done worse and not developed this. There must be some susceptibility more prevalent in some people.

[koolx]

i got a bit of scar tissue. its bent only 20 degrees to the left caused by penile injections. my uro didnt detect significant scar tissue. but cautions that i stop injections. but its the only thing that gives me erect. i got 3 questions:

1 - will my penis be curved forever or will it go away?

2 - am i good candidate for xiaflex?

3 - does anyone know when xiaflex will be released?

[james1947]

Koolx

1 - will my penis be curved forever or will it go away?

Very rarely will go away without treatment

2 - am i good candidate for xiaflex?

Just your uro or a Peyronies specialist can answer to that.

3 - does anyone know when xiaflex will be released?

Most recent updates
Xiaflex trials are over, maker files with FDA for approval for pyronies - Peyronies Society Forums

James

[Noway]

koolx

since xiaflex is looking really positive and actually gets injected into the penis and right into the scar tissue is a bonus. Just try everything and when xiaflex comes out try that I would exhaust everything before you think about surgery. Its not really if your a candidate for anything its what your willing to do and try. Doing nothing will be that result nothing. Find a treatment that works for you a certain treatment that works for one person may not work for another it depends on alot of factors.  

[funnyfarm]

I think the study results are marginally positive, and they did not publish info about those with negative outcomes.   And you are assuming it is safer than surgery, which I think may be the case in the hands of the right doctor, after he has gained experience with enough patients.   Finally, I hope this is not the case however it is possible, similar to injectable steroid therapy, that surgery is not a viable option after xiaflex in some people due to undesirable changes to the tissue.  

I hate to say it but from a financial standpoint, the best case scenario for the manufacturer would be a drug that requires new injections every few years, and eliminates the option to have surgery after you are injected.   Unfortunately the lesson we can learn from the pharma industry is that treating symptoms is almost always more profitable than a cure because it creates lifelong customers.  

I hope things are more positive when the drug is released,  I just don't want to get my hopes up too high.  

[bigthumper]

I am currently in the research for the drug Xiaflex. I finished my 4th cycle of 2 shots on Xiaflex directly into the affected tissue in the penis. I can tell you this it works but not a total cure.. I have lost over half the cure which is great. it looks good again..Hang in there guys there is help on the way

[RoyHobbs]

Did you participate in the original trials?

[bigthumper]

I am currently in current research study. " A phase 3, open label study of the safety and effectiveness of AA4500 (xiaflex) administered twice per treatment cycle for up to four treatment cycles (2X4) in men with peyronies disease". and there has been an improvement.

[james1947]

bigthumper

I was thinking the study has ended.
Can you give us some more detail regarding the treatment and the improvements?

James

[bigthumper]

I participated in a blind test study first, but the first time i received the placebo.
After the test was completed i was told that i could receive the real drug. The study consisted 4 injection cycles. Each cycle took 3 office visits in one week. the cycles were a month apart. a session consisted of, first session: an injection of Trimix ( in the penis) to get an erection and measurement of the cure the an injection to relieve the erection then you get the injection of xiaflex at the point of the curve, second 48 hours later was another injection of xiaflex in the area of the curve, third session was modeling which is bending the penis in the direction opposite the curve. the injection of xiaflex did hurt but was quick and not unbearable. The cycles were a month apart. I am finished with the 4 sessions now I have 2 more visits a month apart for measurement of the curve.
There is improvement, the curve has not totally disappeared but is far less. I do not know how much longer before the drug is released.

[damian]

bigthumper

Any length and girth improvements?

[MattFoley]

There is improvement, the curve has not totally disappeared but is far less. I do not know how much longer before the drug is released.

When you say "improvement", what degree change has there been?

[yyy]

I've read that the Trial consisted of 1 injection each month.
I'd like to know exactly what was the % of the drug injected.

[agent0]

does anyone know if xiaflex could somehow cause some degree of erectile dysfunction?

[agent0]

so xiaflex gets approved next month right? in September? i cant wait

[jackp]

My understanding is that the FDA will met September 6. At that time they will decide on Xiaflex.

Jackp
http://jackp-penileimplant.glogspot.com

[agent0]

so if they approve it. how long would it take for us to get the injections?

i need this. im so tired of being numb i need my life back.

[Forester]

agent0 I admire how you have been able to keep it together for over 5 years...I have been dealing with peyronies/sexual anhedonia for about half that time and I feel like I am going to crack any minute now. I would still not rush into Xiaflex just yet...best for them to work the kinks out first it is still a very new drug (for peyronies anyway)

I am going to send you a PM today please look out for it.

[agent0]

yeah, i feel like im gonna crack too. sometimes i get panic attacks thinking il be numb forever, but then i pray and just keep my mind off the subject by hobbies or talking to my gf. that really helps. it really helps for someone to listen and for that i am forever in debt to her. as soon as my uro can prescribe it to me. im taking the injection.

[MattFoley]

agent0, it's great that you have a girlfriend. I lost mine over this nightmare disease. I work non-stop to keep myself from losing my mind.

[Craig]

Copied quote removed by moderator

Wow these exact words could have came out of my mouth. Describes my situation exactly.  

[agent0]

craig, do you have sensation problems? like numbness?

[watcher]

bigthumper, have you noticed an increased hardness in erections as well as decreased curve?

[agent0]

Is it possible for xialex to get rid of a venous leak if you get rid of the plaque?

[james1947]

Agent0

In my opinion don't have connection between the plaques and venous leak just if the plaque is located in the area that the veins should close to maintain an erection, but I am not a doctor.

James

[jackp]

AgentO

My wife and I are part of the Peyronies Awareness program being done by Xiaflex. We did a video in July telling our peyronies journey. It was not scripted and in our own words.  During that time I had a long talk with the Xiaflex rep.  A lot of information I have is confidential until after it is approved by the FDA.

The one thing I can tell you Xiaflex will not help venous leakage.  

Jackp
http://jackp-penileimplant.blogspot.com

[MattFoley]

Agent0,

Yes, James is correct, there is little to no correlation between Xiaflex treating the bend and the venous leakage problem. And as James stated, if the plaque is in the dorsal area then, yes, there may very well be some benefit to the venous leakage issue. Why? Because the plaque in the dorsal area is what is keeping the penis from being able to close off the vein tightly. If Xiaflex makes the plaque more pliable, then a chance exists. So, let's pray it does that.

[Forester]

Agent0,

You might want to give this doctor a visit:

Pain Relief for Neuropathy Pain, Joint Pain, Foot Drop, Pelvic Pain, Groin Pain

He is a neurosurgeon that can perform nerve decompression surgery on the dorsal penile nerve.  If your numbness is caused by a compressed dorsal nerve there may be hope yet.  I am thinking about seeing this doctor too if pentox and injections fail to help.

[MattFoley]

By the way guys, I spoke to Dr. Lue today and he told me that he's ready for Xiaflex. He knows where and how to do the injections so there will be no ramp up time for him. The only thing standing between me and Xiaflex is the insurance coverage. I'm praying that the insurance company will pay for it.

[agent0]

will do forester

[RoyHobbs]

My google alert on xiaflex led me to this-

Auxilium Pharmaceuticals, Inc. (AUXL): Auxilium: Serious Red Flags Make The Upcoming FDA Decision For Xiaflex A 'High Risk' - Seeking Alpha

"Analysts at Brean Capital expect FDA rejection of Xiaflex in Peyronie's disease primarily due to their view that the Peyronie's PDQ generated borderline statistical significance and that there were many dropouts not included in the analysis."

We're four days away from a decision. Take this with a grain of salt, gentlemen. Analysts are paid to analyze. It doesn't mean they're right. However, even if approved we have to remember what may help some will not help all. Does that mean if Dr. Lue tells me it could help and we should give it a go I won't? No, I will. Because otherwise it's likely surgery for me.

[james1947]

I agree with you RoyHobbs but hope it will be approved. Even if it will help just let say 15% or 20% of the Peyronies sufferers, for them it will be 100% success

James

[RoyHobbs]

When it comes down to it, if you search long enough you'll find an article that agrees with your position (or rather your level of hope):

3 Biopharmas Hoping for Good News From the FDA

[MattFoley]

The general public has no idea the horror for a man to have to deal with this every day for the rest of their lives so getting Xiaflex approved and even getting a small benefit, like James said, is well worth the effort.

[RoyHobbs]

I whole heartedly agree, Matt.

[Litani]

I went for a physical yesterday to my regular doctor. This was the first time after peyronies. He asked if there was anything new and I told him about my peyronies. It was the first time he heard it. He was asking me all sorts of questions. So it is not only the general public.

[jackp]

Litani

That was one of the things brough out in our Peyronies Awareness video. Not only do urologist need to be educated on peyronies but the whole medical community.    

Jackp
http://jackp-penileimplant.blogspot.com

[MattFoley]

I don't understand how someone can be a urologist and know so very little about Peyronie's. Consider this forum: 80% of what I learned about from Peyronie's is from this website. I know more about Peyronie's than 90% of the urologists out there. What the heck, man? These so-called urologists should be ashamed.

[agent0]

so its dec 6th, does anyone have any info on if xiaflex got approved or not?

[searchmode]

I believe it has been FDA approved for Peyronie's treatment!!!http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377849.htm

[jnstrawn]

Yes, it has!

[nemo]

I know Xiaflex isn't a slam-dunk cure, but this is HUGE, in a disease that has never had any HUGE news before insofar as treatments.  Pentox is probably as close as we've gotten.  

Hope springs eternal!  

Nemo

[ThisWontWork]

I believe it has been FDA approved for Peyronie's treatment!!!http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377849.htm

Unbelievable ...!!! This is all about money. FDA is corrupt! I participated in the trial Phase 3. I got all 8 shots and that did nothing at all!

But if you believe in this - go for it. It´s all about the "placebo-effect". You can take what ever and the "placebo-effect will help your body to heal your decease.  

[damian]

Ok. We wont even try this, because it didn't help you. Thank you, we'll wait another 10, maybe 20 years for a new treatment and don't even bother with this.

[james1947]

I will repeat what I have said in an other place:
Even it will help 20% of the Peyronies sufferers it is OK with me.

James

[George999]

http://www.washingtonpost.com/national/health-science/fda-approves-xiaflex-to-treat-peyronies-disease/2013/12/06/7b845096-5ea8-11e3-bc56-c6ca94801fac_story.html

[MikeSmith0]

It didn't help a lot of people in the trial.  The average improvements numbers are pretty low compared to the placebo (34% improvement with xiaflex vs 18% improvement w/ placebo).  I am sure tons of patients will want this now - and they have no other option (verapamil doesn't work) - but there are still a few open questions: How well will it do under less controlled conditions (they excluded anyone with a hinge effect or narrowing, and no angles under 30 or over 90)?   Will insurance cover it?  If they insist on pricing it at $4000 a vial before doctor's fees... insurance might just make you have surgery.  My former insurance excluded xiaflex for duputreyn's completely (and it was a major insurance company).  The surgery was much cheaper.  Surgery for peyronie's has more side effects, though...so who knows.  Insurance usually cares about $ and not if your penis shrinks.

Another problem is that xiaflex cannot restore elastin or decrease generalized fibrosis or thickening.  Many people have these issues with their Peyronies Disease.  The plaque isn't the whole story, and that's probably why people had mixed results.  Some have felt the plaque dissolve over the years but the curve and narrowing never went away.

I still think this page has good info on the negative side of xiaflex, even though it's outdated as of today now that it is approved:  Auxilium Collagenase (Xiaflex) for Peyronies Disease - Clinical Trial Side Effects and Discussion

I'm not surprised it was approved because there's nothing else to treat this - and hopefully it will help some people - but they need to be more honest about who it is really going to help & why it won't help everyone.  

[jackp]

Xiaflex was approved by the FDA today.  

I don't have a release yet to tell what I know but let me say this. It is not the cure all everyone is looking for.  I know several on this forum, and there doctors, that are ready to administer it that do not meet the guidelines.  It is still to be seen if it will be covered by insurance and Medicare.  This is one of the points I brought out in the Peyronies Awareness video my wife and I did in July.  Now that it is approved I am looking forward to getting a copy of the video.  

The biggest fear about Xiaflex several doctors have is it will be over used and used on patients that do not qualify and give it a bad name.  That will not help those that do qualify.  

If you go the Xiaflex route check out the doctor and his credentials. Most General Practice Urologist do not have the proper qualifications.  

Good Luck to all. For those that qualify it will be a great treatment.

Jackp
http://jackp-penileimplant.blogspot.com