Medication Articles

OPIODS – CHRONIC PAIN – ADDICTION – DEPENDENCE – TOLERANCE – What’s the Difference?

By Keith Orsini 2008 

HOW DO THEY RELATE TO THE RSD/CRPS PATIENT?
WHAT IS THE DIFFERENCE BETWEEN ADDICTION, DEPENDENCE, AND TOLERANCE?
DO CHRONIC PAIN PATIENTS TYPICALLY BECOME ADDICTED TO OPIOD MEDICATIONS
PAIN MANAGEMENT: DRUG TOLERANCE AND ADDICTION

In an article written by WebMD in collaboration with the Cleveland Clinic states, “Some medications used to treat pain can be addictive. Addiction is different from physical dependence or tolerance, however. In cases of physical dependence, withdrawal symptoms occur when a substance suddenly is stopped. Tolerance occurs when the initial dose of a substance loses its effectiveness over time. Addiction and physical dependence often occur together.” People who take a class of drugs called opioids for a long period of time may develop tolerance and even physical dependence. This does not mean, however, that a person is addicted. In general, the chance of addiction is very small when narcotics are used under proper medical supervision.” The article goes on to say, “Most people who take their pain medicine as directed by their doctor do not become addicted, even if they take the medicine for a long time.” 

TO READ THIS ARTICLE IN ITS’ ENTIRETY, CLICK HERE 

CLICK HERE to read the article from WebMD

​New Medication For Treating CRPS in 2015?  Neridronate is a new Bisphosphonate

​CLICK HERE IF YOU ARE INTERESTED IN THE NERIDRONATE TRIAL STUDY 

What’s so different about this medication?

Here are the details so far on one that was used over in Europe that showed great promise. 

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

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 have a CRPSRESEARCH/TRIALS/STUDIES page you can check on for the NIH, NINDS, and ClinicalTrials.gov 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.

ARTICLES AND STUDIES ON NERIDRONATE 

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?

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 Howard Black’s Library)
Efficacy of Pamidronate in Complex Regional Pain Syndrome Type I

STUDIES FOUR (Howard Black’s Library)
Effect of Immunomodulating Medications in Complex Regional Pain Syndrome

STUDIES FIVE (Howard Black’s Library)

MORE PAMIDRONATE INFORMATIONANSWERS 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 currently 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.

As a patient myself, 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. Patients in the kind of pain CRPS patients are in can sometimes be so desperate for relief they will try anything for help, especially when they hear the word “cure” being tossed around. Please do your homework before starting any new regime. 

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?

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

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

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. 

PSS The first trials started around April of 2015 and are continuing (May 2016). There has been some difficulty in obtaining the requisite number of patients for the study due to the stringent requirements imposed by the study. 

​AXS – 02 – SECOND CRPS-SPECIFIC MEDICATION GIVEN FDA FAST-TRACK APPROVAL

CRPS specific Medication given fast-track approval by the FDA in March, 2015 and their study began in July of 2015!

You can read the article regarding their approval HERE 

​THE AXS-02 (oral zoledronate) STUDY

WHERE CAN I READ ABOUT THE STUDY AND APPLY TO BE PART OF IT? 

Read about the AXS-02 Study, the specifics, and how to find out if you can qualify to be a part of it by clicking on the link below! A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1

ClinicalTrials.gov identifier: NCT02504008

WHO IS THIS NEW MEDICATION DESIGNED TO HELP?
Patients who suffer from CRPS Type IAKA RSDS. Remember, CRPS Type I is different from Type II.
You can read about those differences HERE.
The majority of those diagnosed with CRPS have Type I or what used to be known as RSDS, or Reflex Sympathetic Dystrophy. There are some websites and Facebook pages on the internet with outdated definitions of these terms so please be sure your information is the most recent and correct. WHAT KIND OF STUDY IS IT? HOW LONG WILL IT TAKE? It is a randomized, placebo- controlled, double-blind, 24 week long study. IMPORTANT INCLUSION FACTORS Patients must be 18 years of age and be able to give written informed consent. Patients must have a confirmed diagnosis of CRPS Type I. Have a pain score of 5 or more on a scale of 0 to 10. 

IMPORTANT EXCLUSION FACTORS Patient had a sympathetic nerve block within 3 weeks.  Patient received chronic opioid therapy with 4 weeks. Involved in active litigation or awaiting a workers’ compensation decision. Any other clinically significant medical or pain condition (e.g., cognitive impairment or Fibromyalgia) or clinical abnormality that would, in the investigators judgement, interfere with the patients ability to participate in the study.For more of the inclusion/exclusion criteria and other information regarding the study you can click on the link below.AXS-02 STUDY PAGE