Have you see this? Perhaps this is good news for Type 1? I sure hope so!! I wish they would do a study on type II as well. Perhaps it is good news for all of us. Now then.. how do we get the FDA not to drag their feet?

Many hugs, Vrae

American RSDHope

New Medication For Treating CRPS in 2014? Neridronate is a new Bisphosphonate

If the FDA approves it, there could be a new medication coming to treat the symptoms of CRPS as early as this year, 2014!

What's so different about this medication?

There is also NEW HOPE on the horizon for CRPS patients in 2014. There is a possibility of a medication being developed to help treat the symptoms of CRPS. We will share what we know and more as we learn more and as the studies progress.

Here are the details so far...

Neridronate is a new amino bisphosphonate for the treatment of osteopenia, but an amazing thing happened when it was tested against CRPS (#6).

Every patient, all of whom had CRPS TYPE 1, who was infused with the drug, was free of all CRPS symptoms one year later! The trial included the opportunity for placebo receivers to get a supply of the drug if it showed excellent activity, so every person enrolled in the study was symptom free, according to the study. The company is filing with the FDA to have CRPS added as an approved indication.

This would be the first drug on the market specifically approved for CRPS!


We don't anticipate the drug being made available to the general public anytime soon. Hopefully the FDA will move quickly based on the amazing results of the drug trials in Europe coupled with the fact that there is no other disease-specific drug available to CRPS sufferers and the disease is so painful. We anticipate the FDA requiring new trials/studies here in the USA before the drug is made available to the public. Early feedback from the research community seems to be that perhaps more research needs to be done before a release will be made next year.

As excited as we all are for the drug to be released to all CRPS patients we need to be patient, we need to let the FDA do its job of protecting us and ensuring that the drug is as safe and as effective as everyone hopes and anticipates. CRPS is a very, very complicated disease and the sympathetic and autonomic nervous systems are extremely complex. These systems affect every aspect of your body and its function so any medication that treats it, especially one that is touted as treating it so completely must be extremely potent even if it only puts it into remission.

STUDIES/TRIALS
We must be patient, look for and wait for the trials. We have a RESEARCH/TRIALS/STUDIES page you can check on for the NIH which will show any new studies coming out that you can sign up for if you wish to be a part of them.
You can visit that page BY CLICKING HERE.


For more on this exciting news check out the article from DovePress Journal,
Therapeutics and Clinical Risk Management;
-------------------
Definitely read the article in its' entirety and pass it along to your own Drs if necessary.

ARTICLES AND STUDIES ON NERIDRONATE

For more on this exciting news check click on the article from DovePress Journal,
Therapeutics and Clinical Risk Management;

1 - Clinical development of neridronate: potential for new applications

2 - Rheumatology magazine; Volume 52, Issue 3 - Treatment of complex regional pain syndrome type I with Neridronate: a randomized, double-blind, placebo-controlled study. Objective. Complex regional pain syndrome type I (CRPS-I) is a severely disabling pain syndrome for which no definite treatment has been established. The aim of this multi-centre, randomized, double-blind placebo-controlled trial was to test the efficacy of the amino-bisphosphonate neridronate in patients with CRP-I.

Click on the link to read the entire study and article.

3 - Bisphosphonates For Early Complex Regional Pain Syndrome - Neridronate, an aminobisphosphonate, has shown promise in reducing the often extreme and intransigent pain of complex regional pain syndrome. Welcomed clinically, what can this finding tell us about the enigmatic mechanisms of bisphosphonates and of complex regional pain syndrome alike?


More coming (SEE BELOW)

Send your NERIDRONATE or related studies, or your Questions to Keith via email here so he can add them here for others to read.




ANSWERS TO A FEW QUESTIONS THAT HAVE ARISEN ALREADY


1) Some of you have asked whether this will be able to help this patients with CRPS Type II as well as Type I?

I don't know the definitive answer to that. What I do know from reading the material out there so far, the studies that have been done, is that it appears to have very good success against CRPS Type I in the studies that have been done already. As soon as we have better answers regarding this we will share it with you. You can google even more about this type of drug out on the net.

2) Is this a cure for CRPS?

I realize that it states in the above article that every person enrolled in the study ended up being cured. I would really love to believe that is the long-term effect of the medication. I think we have to take a wait and see attitude, see how many patients, years down the road, remain completely CRPS symptom free. If it is 100%? Fantastic! Even if it was 75% or something close to that it would be amazing I think, speaking again, as a fellow patient. I am always a little nervous when I hear the word "cure" being used. We get emails every month here at American RSDHope it seems from patients and even some physicians who claim they have found the latest medication, OTC drug, or treatment that is "curing" patients and in the end it turns out not to be the case.

All we can go by is what the results of the studies have shown so far. I will quote from the drug makers;

"Every patient, all of whom had CRPS1, who was infused with the drug, was free of all CRPS symptoms one year later!". Another I read said they followed the patients many years more than that and they were still completely "symptom free". They also called them "cured". Personally, this is just me as a patient talking and not as some kind of an expert but personally I do not like the term "cured" used when it comes to CRPS.

It is a chronic illness and the worst kind of chronic illness because even in the best of circumstances, complete remission, a patient could injure themselves, slip, fall, stumble, have surgery, even the simplest thing, and end up with a recurrence of the disease. I have heard the stories directly from patients formerly in remission and I personally have been in remission, had a fall and gone back to 100% full body CRPS within two weeks. So let's go with "Symptom Free" instead of cured.

BUT, even if it all it did was "significantly improved" a CRPS patients symptoms, I believe every single CRPS patient we know would be beating down their door, as I recently read on a website, to get in line to be treated by this drug because there simply has not been a disease specific drug for CRPS before.

3) What does it mean for a drug to be Fast-tracked by the FDA?

A) Normal track approval process - typical approval process for most drugs approved by the FDA
explains how it typically works

B) FASTER APPROVAL PROCESSES - (there are three different types of the faster approval processes)

Fast Track approval process is the one that the CRPS drug is on because of the obvious reasons; there isn’t any current medication available for our disease and it is a disease that progresses rapidly from a mild condition to a much more serious one, etc. It is also a drug that has been under use and study in Europe for a while already and that helps a lot. They have a body of data from which to draw from already.

There are others out there who know far more about this stuff than I do but this is what I understand about the process. Check out the FDA websites linked above for more information on the process and the links to the medication and the trials above for more info on the drug.

Peace,

Keith Orsini
American RSDHope
January - 2014
Updated - June 2014

PS - Many people have written to us asking if we would recommend that they travel to Italy or other countries where the drug is currently approved already. Because our own FDA believes more needs to be studied before the drug can be approved and released to the general public this is not an action that American RSDHope can recommend at this time. As always we recommend you discuss any medication issues with your Doctors, do as much research as you can and together, as a team, come to your decision. Always remember that CRPS is a long-term, chronic illness and you need to think long-term in your treatment options.



FURTHER STUDIES

FURTHER STUDIES YOU CAN READ REGARDING NERIDRONATE AND OR BISPHOSPHONATES (I apologize if any of these are repeated)

STUDIES ONE -
A New Highly Effective Treatment for CRPS/Reflex Sympathetic Dystrophy

STUDIES - TWO
Bisphosphonate therapy of reflex sympathetic dystrophy syndrome

STUDIES - THREE (FROM THE RSDSA LIBRARY)
Bisphosphonates for the therapy of complex regional pain syndrome I – Systematic review

STUDIES - FOUR (ALSO FROM THE RSDSA LIBRARY)
Treatment of complex regional pain syndrome: a review of the evidence

STUDIES - FIVE (From Howard Black's Library)
Efficacy of Pamidronate in Complex Regional Pain Syndrome Type I

STUDIES - SIX (Howard Black's Library)
Effect of Immunomodulating Medications in Complex Regional Pain Syndrome

STUDIES - SEVEN (Howard Black's Library)

MORE PAMIDRONATE INFORMATION

So,far I heard ,is still on the trial part and process might take longer time to be our specifically for rsd . Still he beginning I wasn't even considering trying anything new until few years on the market but soon I realized ,dawn ,I'm not getting better as faster As I wishes and needs to really tries whatever is out there to regain myself back .
I got lay off recently and my world is turning upside down,I need some peace and soon,my stress levels are making my rsd getting worse and worse .hope something can't change the future of rsd therapies soon.
Gentle hugs and lots of love Vrae. See you soon and blessings as well thanks for the info and the links,new links I will add to my journal, from Jesika.