Tag Archives: xiaflex

Should I get my hopes up about Xiaflex for Peyronies and Dupuytrens?

Posted on by Dr.Herazy

I've been reading that Xiaflex (used for Dupuytren's contracture) was tested for Peyronie's disease with pretty successful results and could be on the market as early as this year.  Should i get my hopes up?  Is this worth being excited about?

Greetings,

I am hearing more and more about nasty side effects and bad reactions from Xiaflex injections for Dupuytren contracture.  I think this is – or should be – the reason that Xiaflex has not been given fast approval for Peyronie's treatment.  I hate to think of what might happen if Xiaflex begins dissolving normal soft tissue structures in the penis as it sometimes does in the hand. 

From the tone of your email I get the sense that you are genuinely hopeful about Xiaflex might do for you, because you feel so helpless against Peyronie's disease.  Most men feel this way. You can get your hopes up, and you can get excited about it, if you wish.  Many people are sitting around waiting for a medical miracle cure while their lives slip away with a curved penis or useless hands.  They have the attitude that if there is no drug to save them, there is nothing to help them because the body cannot do anything against Peyronies disease or Dupuytren contracture.  Personally, I do not accept that line of thought.  I have seen too many people injured by drugs, like Xiaflex, and helped by Alternative Medicine. 

I believe a far more rational and safe approach to treating these two problems, and many others, is to first attempt more conservative treatment using a wide variety of simultaneous Alternative Medicine treatment methods.   Only after exhausting all possible conservative options would I remotely consider taking the calculated risk of a drug like Xiaflex.   The tone of your question suggests to me that you are not aware of, or even considering, the possible harm that can be done with a drug like Xiaflex.  

Many new drugs come on the market each year because of glowing reports and spectacular enthusiasm for the wonderful research results.  The new drug is highly advertised and heavily used for a while.  Then slowly and quietly new information comes out that bad things are happening to those who take this new wonder drug.  Even more quietly the drug is removed from the market a year or two later.  How many times have you heard that same story played out over and over?  High hopes based on questionable research, people hurt, drug withdrawal, many lawsuits. 

Why do we see so many TV commercials from lawyers who are trying to sue the pants off these drug makers?  The legal profession has created this large industry for themselves because there are so many bad drugs on the market and so many people who are injured, that lawyers can profit from this misfortune.  What should that tell you?  The lawyers are not making this stuff up.  They are just taking advantage of the huge opportunity they are given by bad drugs and injured people. 

Fact:  The U.S. is the heaviest user of drugs and surgery.  Fact: The U.S. is ranked about the 16th healthiest nation in the world, and we die at an earlier age, behind 15 other countries that take fewer drugs and use less surgery than we do.  If the use of drugs and surgery leads to health and long life, we should live the longest and be the healthiest country and we are not.  What does that tell you?

Sure, there are good drugs and not all drugs are bad.  But you must be extremely careful how you go about using them.  Xiaflex might help you, I cannot say one way or the other.  In my opinion, if you are going to use Xiaflex it should be the last thing you do, not the first thing.  You should certainly talk to your doctor about your decision and educate yourself to the best level you can.How you approach the treatment of your problem is your decision.  TRH 

Peyronie's disease treatment with Xiaflex

Posted on by Dr.Herazy

Peyronie's treatment with experimental drug, Xiaflex

Peyronie’s disease is best known for the plaque, scar or hard lump that causes a curved penis to develop. Peyronies begins as a localized inflammation, usually as a result of injury of some type. It is currently believed that Peyronie’s disease is caused by vascular trauma or injury to the deeper penis anatomy. Peyronie’s disease is most common in men over 50 years, and the incidence increases with age. This inflammation often progresses to a hardened plaque or scar that reduces flexibility of the tissue of the penis, and results in a bend or distortion during erection due to incomplete filling or restriction of the tissue. Often, this causes constant pain or pain during erection, and for some men these can prevent sexual intercourse due t physical incompatibility or erectile dysfunction.

Aside from the physical changes, depression and reduced self-esteem are commonly experienced by men with Peyronie’s disease.

Peyronie’s disease is most often treated by urologists, even though there are no approved drug therapies for Peyronie’s disease. Peyronie's surgery may be an option for some patients although complications such as worsening of the PD distortion can develop, as well as loss of penile length can occur. Xiaflex, a type of collagen reducing enzyme, or collagenase, has been experimentally injected into the Peyronie’s disease scar or plaque as an in-office procedure. The purpose of injecting Xiaflex into the Peyronie's disease scar is to soften the scar tissue and improve or reduce the curvature of the penis. Further, this is hoped to improve sexual function and eliminate the distressing negative psychosocial aspects of Peyronie’s disease.

Peyronies Xiaflex trial results

Sponsored and monitored by BioSpecifics Technologies Corp., licensor of Xiaflex, the 12 month phase II open-label trials of Xiaflex showed limited but promising results. These research tests were conducted to evaluate the ability of Xiaflex to successfully treat Peyronie's disease, as well as its compatibility and side effect potential. In this process clinical success was defined as a baseline change of penile angulation of at least 25 percent.

Each of the study participants received three injections of Xiaflex, administered on a separate day, and given over seven to ten day period. Twelve weeks later, each man received a second series of three injections. Research subjects were evaluated at three, six, and nine months after the Xiaflex injection series.

The average baseline angulation was 52.8 degrees. In this study clinical success was achieved at three and six months with 58 percent and 53 percent of patients, respectively. This would suggest that early success might not last very long or that the improvement to the Peyronie’s disease distortion was temporary.

In this study there were adverse reactions with Xiaflex that were not described in the general media. The most common adverse reaction was only reported as a problem at the local administration site that was mild or moderate in severity, non-serious, and resolved in time without medical attention. No comment was made about worsening of the Peyronie’s disease after the nine month time frame as a direct result of repeated injury to the delicate tunica albuginea tissue from the multiple needle injections of the needle used to deliver the Xiaflex.

It is the opinion of PDI that for some men these repeated injections could make their Peyronie's disease condition worse over time. It might be prudent for the average man to wait until more clinical treatment results are collected and interpreted before considering this treatment approach.

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Peyronie’s disease treatment with Xiaflex

Posted on by Web Designer

Peyronie’s treatment with experimental drug, Xiaflex

Peyronie’s disease is best known for the plaque, scar or hard lump that causes a curved penis to develop.   Peyronies begins as a localized inflammation, usually as a result of injury of some type. It is currently believed that Peyronie’s disease is caused by vascular trauma or injury to the deeper penis anatomy. Peyronie’s disease is most common in men over 50 years, and the incidence increases with age. This inflammation often progresses to a hardened plaque or scar that reduces flexibility of the tissue of the penis, and results in a bend or distortion during erection due to incomplete filling or restriction of the tissue.  Often, this causes constant pain or pain during erection, and for some men these can prevent sexual intercourse due t physical incompatibility or erectile dysfunction.

Aside from the physical changes, depression and reduced self-esteem are commonly experienced by men with Peyronie’s disease.

Peyronie’s disease is most often treated by urologists, even though there are no approved drug therapies for Peyronie’s disease.  Peyronie’s surgery may be an option for some patients although complications such as worsening of the PD distortion can develop, as well as loss of penile length can occur.   Xiaflex, a type of collagen reducing enzyme, or collagenase, has been experimentally injected into the Peyronie’s disease scar or plaque as an in-office procedure. The purpose of injecting Xiaflex into the PD scar is to soften the scar tissue and improve or reduce the curvature of the penis. Further, this is hoped to improve sexual function and eliminate the distressing negative psychosocial aspects of Peyronie’s disease.

Peyronies Xiaflex trial results

Sponsored and monitored by BioSpecifics Technologies Corp., licensor of Xiaflex, the 12 month phase II open-label trials of Xiaflex showed limited but promising results.  These research tests were conducted to evaluate the ability of Xiaflex to successfully treat Peyronie’s disease, as well as its compatibility and side effect potential.  In this process clinical success was defined as a baseline change of penile angulation of at least 25 percent.

Each of the study participants received three injections of Xiaflex, administered on a separate day, and given over seven to ten day period.  Twelve weeks later, each man received a second series of three injections.  Research subjects were evaluated at three, six, and nine months after the Xiaflex injection series.

The average baseline angulation was 52.8 degrees.  In this study clinical success was achieved at three and six months with 58 percent and 53 percent of patients, respectively.  This would suggest that early success might not last very long or that the improvement to the Peyronie’s disease distortion was temporary.

In this study there were adverse reactions with Xiaflex that were not described in the general media.  The most common adverse reaction was only reported as a problem at the local administration site that was mild or moderate in severity, non-serious, and resolved in time without medical attention.  No comment was made about worsening of the Peyronie’s disease after the nine month time frame as a direct result of repeated injury to the delicate tunica albuginea tissue from the multiple needle injections of the needle used to deliver the Xiaflex.

It is the opinion of PDI that for some men these repeated injections could make their Peyronie’s disease condition worse over time.   It might be prudent for the average man to wait until more clinical treatment results are collected and interpreted before considering this treatment approach.