Developmental drugs & treatments - Still in trial or not approved for Peyronies

[McNally]

What I should have said was that a simple injection may not turn out to be the most effective way to use it.

As a study participant, my impression is that the current Xiaflex study is taking a very conservative approach to the injection protocol, and that if it's approved a more aggressive injection schedule might be used.

[bones54]

to market by next year?

doubt it.  being in the study, they will be observing/measuring for the next 9 months...

maybe 2 years--if its effective.

[j]

Gregory, I think the cost of Xiaflex treatment has yet to be worked out. What we've heard so far are the wild revenue projections Auxilium has given to prospective investors.  Their presentations have crowed about how Xiaflex will command "a premium price" (their language) because it's supposedly the only alternative to surgery for Dupuytren's.  The latter statement is not true - there's an excellent non-surgical techinque called "needle aponeurotomy" that's gaining in popularity. The former statement may not turn out to be true either.

Auxilium has to come to terms with the insurers if they want a market for the product.  

[Gregory]

Yes, I guess I am overly optimistic and I have to hold on to some hope.  This has been doubly devastating for me.  First, to have deal with prostate cancer and the side effects of that and then to be hit with Peyronies Disease on top of it.  I am blessed that the cancer seems to be gone.  Jury is still out on that.  I hasn't been two years yet after my surgery.  I knew I'd have to deal with ED issues but given the alternative, I chose a life of possible drug or injection induced erections rather than no life at all.  

I was so excited to see that there is a good possibility of a good treatment if not an outright cure in Xiaflex.  I feel like a little kid waiting for Christmas to come and the wait is painful.  I know that there has to be sufficient research and trials to measure efficacy and safety.  I just wish that this would get moved along quickly.  Some stats say this affect 1%, others as much as 5%.  Those are still big numbers when you think about it.  The emotional side of it needs to be factored into just how serious this is.  I don't want to hear, "oh, it's only a penis. Get over it."  I realize more than ever just how important a penis is, not only to the man, but to the woman or partner and that relationship.  Our sex lives are important to our wellbeing.  This is a cruel disease that causes so much pain.

As for the cost, well, the price will be determined on what the market will bear.  How much would any of us be willing to pay to have this curse taken away?  

Greg

[ComeBacKid]

Then if i'm reading you correctly, your saying in all likelihood the price of xiaflex will be cheaper than the exaggerated claims made by auxillium?  They aren't going to tell investors "yeah we got a great product and we want to sell it at a dirt cheap price."  I totally read you on this one.  Its like the last company I worked for crowed to investors and shareholders that we sold an "incredible service," which allowed us to get "premium prices for our goods."  Despite the fact that the competition was selling the same products at 25% cheaper than us.  Its all jibberish bs talk to keep greedy investors happy.  I'd just ignore it.  Personally I'm just interested in hearing about the actual study results to see if the product WORKS.  I'm sure it will be somewhat expensive, but i'm sure most guys wont mind taking out a credit card loan to get the treatment if its proven to work.

Comebackid

[Tim468]

Gregory: "I don't want to hear, "oh, it's only a penis. Get over it." "

You won't hear that on this web site!

I expect that it will help some men, and it will be hyped, and it will not help others and when the dust settles, the price will too. To be competitive, it HAS to be an alternative to surgery, and it has to be cheaper.

Tim

[j]

Companies like Auxilium do need to beat the drums to get investment money, otherwise nothing ever happens - no Xiaflex.  I did however find their use of the term "premium price" a bit grating. It implies that they think they can really shake down patients, who have no other option.  It's not something they should have said out loud, or in print.

Peyronie's surgery has a relatively  poor track record.   So if Xiaflex actually worked in, say, 60% of the cases and at least did no damage to the other 40%, you could say it's "better".  Does that mean it should cost more?  How does "supply and demand" play out here? What would the insurers decide? Do they get to see Auxilium's books so they know the real cost of production? I don't know.  

The reality though is that Xiaflex is a product, and there's a market for it, and a price will be found.  

[ComeBacKid]

I imagine that price will be found at a patients willingness to spend money to cure their penis, and take away all the emotional suffering we have bottled up inside. This is assuming the product works on most people.  I imagine a lot of people would probably be willing to take out a $5,000 credit card loan to pay for treatment, if there was promise.  I'm sure the price will be high, I don't worry about that, I worry will the product actually work?  There are no other real treatments in the pipeline, so for now I keep taking my pentox like candy!

Comebackid

[Iceman]

i really feel like i am improving and its not imaginary - the other night after ved usage i could see that it was straighter and longer - i really believe that its a combination of 1 year on pentox 3 times a day and daily usage of ved - i even took it overseas with me - i very diligent like that - using ALC plus l argine and lately tribulus may have helped as well - but i will keep on pumping and taking pentox till there is something else as I an crap scared that the pain will one day return .

[Hitman]

personally i don't see myself pumping the VED and taking pentox in 2-3 years time. if things don't resolve then I will schedule for Surgery.

[ComeBacKid]

I'm not telling you what to do with your penis, you have a choice in what happens to it, the decision is up to you.  Personally though pentox is really the only treatment that has been proven(even if its unscientific) to actually cure or help improve peyronies conditions.  I would only get surgery if it was absolutely necessary, otherwise surgery can go wrong and create more scar tissue.  I'd easily take a pill for two years, and intend to keep doing it this time, why not?

Comebackid

[LWillisjr]

To me it comes down to how long are you willing to wait. Pentox did nothing for me after a year and that was enough for me. There is some data in the "surgery" thread that indicated to me that the risks are lower today with surgery than it was say 10 years ago. And then it comes down to the actual surgeon and their experience.

If one is seeing improvement from Pentox or any other therapy, then stick with it. But when nothing else works how long are you willing to wait and live with your current condition.

[McNally]

imagine a lot of people would probably be willing to take out a $5,000 credit card loan to pay for treatment, if there was promise.

very interesting - when pressed, $5K is exactly the figure my wife came up with to "what would you pay out of pocket to cure this" - personally, that's cheap at twice the price (LOL - sort of).

[j]

Guys - Not so loud, please, Auxilium will hear you - and guess what the price will be...?  

[Believer]

Let them hear - that's the point. If Xiaflex works, I will buy it with ANY price tag. If it means I have to be an indentured servant for 20 years, let it be so. Show me a man on this forum, who will say "I think sex isn't worth that much."

[ocelot556]

I've been doing some cursory looking into about a possible connection to propecia use and Peyronies Disease affecting young men, as I'm in my 20's and it seems other posters of a young age have reported using finasteride before they developd this horrible condition, like me.

I took a look at propeciahelp.com, which has a lot of good forums about it (and they even mention this community favorably on their Peyronie's board). One link I found paticularly interesting, and hadn't seen referenced here:

http://www.propeciahelp.com/forum/viewtopic.php?t=346

and the source: http://contemporaryurology.com/conturo/article/articleDetail.jsp?id=111998

I leave the first link in because it's a long interview and the original poster highlighted the pertinent information. It regards the use of androgen replacement, seperate from testosterone replacement, as the new wave of treatments that will supplant surgery. I'm not sure if these guys are overly optimistic or what - but I figured with other eyes on it maybe it can make a little more sense.

Apologies if this link is already known.

[George999]

Ocelot,  I think this is a very promising piece to the puzzle.  I would certainly like to read more, but the interview in question is restricted to subscribers to the ModernMedicine site.  So there is no access to the content for non-subscribers and it appears that subscribers must be medical professionals.  BUT note that this is NOT about testosterone, it is about ANDROGENS, and one would have to read the interview to know what they are doing with this.  That said, I have long believed that out of whack hormones have a whole lot to do with Peyronie's.  I also believe that the autoimmune process involved, TGF-beta1 etc., is hormonally driven.  - George

[LWillisjr]

J

Peyronie's surgery has a relatively  poor track record.   So if Xiaflex actually worked in, say, 60% of the cases and at least did no damage to the other 40%, you could say it's "better".

I know some here on this forum have had negative experiences with surgeries. But some of these were combined with implant, prostatectomies, or other related issues. I have to admit I'm a bit of an advocate for surgery under the right conditions and as a last resort if other therapies have failed. I've posted this before but let me repeat some documented statistics in favor of surgery.

Dr. Levine has just completed a 14 year study that was just submitted and accepted by the AMA. The study was for 120 men who had undergone surgery for Peyronies Disease. The follow up has been in progress over the 14 year period. My wife and I tried to write this all down after the fact and hope we got most of the numbers close.

1. None of them required a second procedure.

2. 30% of them had some decreased feeling, but some thought this an advantage as they were able to "last longer" for their partners.

3. 20% (I think) had some increased ED in their ability to achieve a firm erection, but all these were treated through the use of drugs like viagra.

4. 5-10% had some recurrence of curvature but not near like they had prior to surgery.

5. (And the one I find important) ALL men were still able to climax and ejaculate during intercourse.

[j]

http://www.marketwire.com/press-release/Auxilium-Pharmaceuticals-Inc-NASDAQ-AUXL-956331.html

[j]

lwillisjr - thanks for posting that information. It has to be encouraging to anyone thinking of going that route.

Those are really good numbers, I can't dispute what Levine says, but I retain some skepticism based on my experience with 2 Dupuytren's surgeries.  I felt they were somewhat oversold with regard to results, and the surgeon's evaluation of the final result was overly positive.  Actually what happened was that during the final visit he looked at my hand, said goodbye and headed out into the hall where he dictated his findings into a pocket recorder - which I overheard. The actual result wasn't as great as what he described. And within a year there'd been considerable regression, which wasn't captured by any followup.  

I think guys should believe Levine's results, but keep in mind that studies like this may tend to emphasize the positives. Surgery is, after all, just a service being marketed.

[MUSICMAN]

I read the report on Xiaflex go for FDA approval. I am not sure if I understand if it could be 60 days or the FDA has up to 6 months to decide?

[ComeBacKid]

Perhaps Tim or J, or someone with some FDA knowledge could give a brief summary of how the process works for us non FDA approval people  

Comebackid

[Tim468]

Not sure I can explain the FDA process, but I will see if I can create a good and short explanation of how it works.

Tim

[ComeBacKid]

Thats kind of what I was hoping for a summary , maybe step by step, you can cut out all the bu@#$@#it information we don't need.

Comebackid

[joe]

I am in the Auxilium study and just received my second set of injections this past Tuesday & Wednesday.  After the first set of injections I didn't see any real change so I was thinking I may be getting the placebo.

I woke up in the middle of the night this Wednesday (after my last injection) in extreme pain. I had a nighttime erection and it felt like someone was ripping my penis off.  It has felt bruised all week.  This morning (Sunday) I woke up with a semi rigid erection, and felt no pain.  I started kissing my girlfriend, thinking I was now ok, but when I got a little harder I was in agony again.  My flacid penis is now purple, swollen, and tender.  

I didn't feel anything like this after the first set of injections.  I am optimistically thinking that maybe I got the real drug, and it is starting to work..  Similar to the Dupuytren's cases where the Doctor snaps the cord after the injection, I thought maybe the pain is the plaque being torn naturally by my erection.  Does this make sense?  Anyone else in the study feeling this level of pain?  Or should I be worried and call the study Doctor tomorrow?  (I will probably call anyway)

-Joe

[ComeBacKid]

Joe,

You probably want to call your doctor just to make sure this a normal response.  Man we haven't heard a lot of good results from people in the auxillium study, this is getting depressing!  I don't like the idea of injecting anything into the penis unless you know it will dissolve the fibrosis, then it will most likely offset any damage caused by the injection itself.  On the other hand, it could be the drug is working, it just may be a painful process to get rid of the plaque, that stuff is hard and may be tough to break up and dissolve.  Keep us posted on what your doctor tells you and if it gets any better.

Comebackid

[Gregory]

Joe,

I would call the doctor.  If you were supposed to have pain or if there was a possibility of it, then he should have told you.  In the absence of a warning, I would think pain is not normal and you should call him.  I hope your theory is correct that the erection is causing the plaque to break up.  Keep us informed.

Greg

[G.]

Joe,

Definitely check in with your doctor tomorrow, but for what it's worth, pain and bruising doesn't seem to be an unusual reaction.  My reaction was a little different from yours (bad bruising after first round, really bad bruising similar to what you describe after second round, and both times, the pain and bruising started about 1 to 2 hours after the second injection of each round).  The condition you describe being in now, sounds really familiar.  If it's any consolation, it might mean it's more likely you're getting the real stuff.

G.

[j]

The MDs don't really know what to expect, it's a new procedure and the patients will have to report what happens.  In the Dupuytren's trials I think there was a farir amount of temporary bruising and swelling afterwards.  I assume the same would happen here so if you get an erection, it could hurt.  

[Hawk]

Man we haven't heard a lot of good results from people in the auxillium study, this is getting depressing!

Reports at this point are utterly meaningless.  Multiply meaningless by ten since know one has a clue if they are getting the drug or not.

[kevin]

I would think that penile tissue undergoing severe treatment like this needs to left alone until a great deal of time has passed.  If there is any chance that healing may be adversely affected by erections during the crucial period, then shouldn't erections really be deliberately prevented?  (There are medications for that.)  The long-term benefits of increased blood flow from erections can surely be deferred for a while without permanent consequences, in the interest of letting the collegenase work without backfiring.

The pain should serve as a reminder of that risk.  With my series of a dozen Verapamil injections (largely unproductive), I had nothing like the pain these trial patients are reporting, except briefly around the actual time of the injection of the substance and the manipulation applied to distribute it through the affected area.  I hope I'm wrong, but we already know how easy it is for the scarring process to start. even with no apparent provocation.  So I would be hesitant to let the tissue get worked up or inflated while still under critical reconstruction, any more than you would run a marathon with a cast on your leg or while still being treated for a heart attack.

[Vernon21]

My doctor said that a certain amount of discomfort and and bruising is to be expected and most likely indicates the real drug.  Also, it can indicate some of the tissue is releasing so it is not necessarily bad.  I may be similar to what they are trying accomplish with modeling.

[George999]

I would be very careful not to prejudge the reports here.  Breaking up established plaque in a short amount of time is unprecedented and is likely to be traumatic.  It could just as easily turn out to be highly positive in terms of outcome as to be negative.  How these patients proceed in the light of these traumatic outcomes would be best left to the judgement of their physicians.  In any case, I believe they should be staying in close communication with their doctors since they are really in uncharted territory.  - George

[McNally]

I started kissing my girlfriend, thinking I was now ok,

Joe, for what it is worth, I was told no sexual intercourse for 2 weeks after the last injection in a cycle (& to be honest, I really didn't feel like it anyway because of the tenderness). But I don't know that we are all getting the same instructions.

[joe]

I was told no sexual intercourse for 2 weeks after the last injection in a cycle

I guess I forgot since I was only bruised for a day or two after the first set of injections and then had no pain.  I wasn't really trying to initiate sex, just kissing and got a painful erection (I will definitely avoid that now).  The first time several days ago was a nocturnal erection that I had no control over though.  I called today and spoke to the study coordinator - she said she'd relay my worries to the Doctor but that they have heard a few similar reports and that it is normal.  She reminded me of the no sex for 2 weeks instruction.  I apologize if I am lowering anyone hopes of the drug or anything like that.  As has been said it is really too early even for me to tell and I don't even know if I am getting the real thing.

-Joe

[jon]

I am not a doctor, nor do I play one on tv, but I was curious if any of you learned gentlemen could impart some medically based opinion on what the lifting of the ban on stem cell research may impart for peyronie's.

[ocelot556]

Stem cell research is more or less an investment in the future rather than applicable technologies available today. This technology is in an early stage. There are "moral" arguments (that center mostly around anti- abortion stances) that worked to hamper that emerging research under the previous US administration - but elsewhere in the world no such restrictions existed, and there are many private interests that were not hampered by the public policy. So research was not stopped completely - it was only deprived of certain avenues of funding.

I wouldn't go so far to say that Mr. Obama's stance will lead to a panacea for human ailments, but it's opening up a rather large pipeline of funds to what many agree is the most exciting line of research of our generation. I'm not an expert on this, but it's certainly an exciting development. More money means faster research and more laboratories getting funding. That can only be a good thing.

[Hawk]

In fact stem cell research has never stopped in the U.S.  This has been an emotional issue in which both sides often tune out facts and take an emotional ride.  There is much research on stem cells that have nothing to do with embryonic stem cells.  In fact advances have made it clear that non-embryonic stem cells have shown value that was thought only to apply to those from embryos.  These advances have reduced the importance of embryonic stem cell lines.

Furthermore, embryonic stem cell research continued uninterrupted.  The restriction was only on newly generated lines of embryonic stem cells.  Research on existing lines has been ongoing

[McNally]

well, no change, still 70+ degree curve, still hourglass deformity  

I still think (hope, because that explains the lack of improvement) I'm on the placebo but will not be able to find out until October - I was told that while the study has not been completed, there has been no noticed correlation between "bruising" and anything else

one more visit to go - 36 weeks & I believe that one includes an ultrasound

btw, was anyone else in the study asked to sign a "revised" consent form?

[Tim468]

Revised consent forms are often created because of some committee finding an objectionable term, changing the wording, and making the investigator change it. I recently had to change a form that did not specify exactly who would tell a parent about a pregnancy if it occurred.

Tim

[MUSICMAN]

By this time most that are in the phase IIb trial have had their 3 rounds of injections of Xiaflex. Can anyone state that they have had s 90% improvement with a bend of 50 - 60 deg? Please send a pm to me, just for my own information on progress.                                                             Musicman

[ComeBacKid]

In regards to MUSICMAN's comment, if anyone has seen that good of improvement, please post it on here for us who are awaiting the results!

[Vernon21]

I have heard unofficially of a 25 degree improvement on an approximately 45 degree bend.  My contact mentioned there have been other improvements but I didn't get specifics.  While it seems there have been improvements, I have not heard of any 100%s, more like a good improvement is a 40-50% reduction over the original bend.  Again, this is just anecdotal and not at all scientific. There may be many other better reports yet to be heard.  I will be back to the doc next month and will ask more, but we should all wait for complete results before passing judgement.

[George999]

This is definitely very good news ... but ... I think the big question here is whether or not this is a lasting fix.  If it is a lasting fix, in other words, if things are still roughly the same or better five years from now, then we have a 'keeper', otherwise, not so good.  And if things stay better for five years, then they will be looking at the potential benefit of a tiered therapy, ie can we get another 50% out of a second treatment (which brings us to 75%) and then perhaps a third round which would effectively cure the problem for most people.  But there are still a lot of unanswered questions.  - George

[newguy]

I have heard unofficially of a 25 degree improvement on an approximately 45 degree bend.  My contact mentioned there have been other improvements but I didn't get specifics.  While it seems there have been improvements, I have not heard of any 100%s, more like a good improvement is a 40-50% reduction over the original bend.  Again, this is just anecdotal and not at all scientific. There may be many other better reports yet to be heard.  I will be back to the doc next month and will ask more, but we should all wait for complete results before passing judgement.

All in all the results sound like a bit of a mixed bag. I wonder if those researching the use for peyronies, will see the results as positive overall.

[MUSICMAN]

In reply to George's thinking is is good news I am not so sure. If a person gets 25% improvement on a 45 deg
bend that still leaves a lot of angle to the dangle. If a person has 80 deg bend he still has lots of problems.
If you have 35 deg bend 25% sounds good. Sure more injections down the road might bring more improvement but that time line is a long way off. Remember phase III will not start until mid 2010 and then a
good deal of time to get drug to market. People on this forum are in various age groups. I for one don't think
I will live long enough to see the full benefit. If I do live that long there might not be a purpose of needing the treatment anyway. Some here with a small bend think they have a big problem, if they had a big bend
then they would know what a problem really is. With the talk of supplements, ved, traction, and so one this is
good for the 30 deg guy but don't feel it will do much for the 80 deg guy. I would make my appointment today for surgery but I am not in a position to financial do it. Stuck between the rock like they say.

[G.]

Now two weeks past my third series of injections, and unfortunately nothing encouraging to report.  I had moderate to severe swelling and bruising after each series of injections, which led me to suspect I was getting the real thing and not placebo, but after all the dust has settled, I don't really see any change.

Oddly, while I was swollen after the third series, I thought I saw a significant decrease in my bend (like a 25% reduction), but as things healed, the decrease seemed to go away and I seem to be back to where I was when this all started.

I guess at this point, I'd have to hope I'm in the placebo group - like everybody else, I won't really know until study is done, which for me would be sometime in August.  Like everyone else, I'm looking forward to seeing what overall results the study gets, and hope they are positive, but would caution that the anecdotal evidence that's coming out might not be completely reliable, unless you're hearing it directly from a study participant.  Guess we all have to hang in there and see what comes out of this, in a few months.

G.

[ComeBacKid]

Where do they inject you at?  The base of the penis?  Halfway up the shaft?  How far in does the needle go?  

Comebackid

[Hawk]

Correct me if I am wrong but I would assume they must inject the plaque wherever that is located.

[G.]

Hawk's about right - the injections are into the plaque.

I do have a few additional opinions and comments about the methodology, but feel bound not to discuss in any detail while the study is in progress - will just have to wait for a while.

G.