[debbiehub]

http://www.rsds.org/3/research/Ziconotide.htm

[Bonnie1014]

Hi everyone! I'm new to the boards and saw this post. I have had the trial and am awaiting final approval for the pump implant with this med. I've had CRPS for going on 10 years, have 17 blocks, acupuncture, acupressure, guided imagery and other relaxation techniques, TENS and SCS, pool therapy, physical therapy, medications, a spinal cord stimulator implanted with a revision to surgically implant paddles for about 4-5 years along with 4 depleted batteries, desensitizing and whatever else was offered to help ease this monster. My daily pain level is between a 7-8. After the trial it dropped to a 5 for the first time in over a year! Nothing else has eased the pain like this medication has. As usual I had to have another MMPI and that was fine. Their concerns were that any psychological issues would increase or occur. I suffer from major depression and have for 35 years, but that's controlled through medications and talk therapy. I cannot say enough about my experience with this med. I wanted to ensure an accurate reading so I was off all pain meds for about 3 weeks prior to the trial. This was not only the strong prescription pain meds, but the Lyrica and anything else I was taking for the RSD. It wasn't pleasant as I'd been on Fentanyl and Dilaudid/Methadone or Actiq for breakthrough this past year trying to find something that would break the flares, along with the relaxation, etc.

Several of our members from our nonprofit asked I journal my experiences with this as it goes along. With so many members we all felt that were a more appropriate forum to journal these events as opposed to bulk emails as not everyone would be interested. I cannot wait for the pump to be implanted. They are going to titrate up slowly of course. The only issue I had with the trial was that it was the standard dosage for a trial, but still too high for my body. For a day or two I was very dizzy and unable to walk a straight line...I couldn't before with the RSD, but this was the walls keeping me from falling, one foot on the floor when I closed my eyes, etc. That lasted a couple of days at most and the pain relief lasted another day or so before it started to return.

For me it was wonderful and well worth having the implant procedure. They will be removing the battery and lead wires to my spine as the SCS stopped working again. The stim was not as effective these past few years and to have the battery replaced evey year was additional proedures I didn't want with the RSD. I cannot remember to charge my cell phone so the rechargable battery was not a good idea for me. After so many times it goes completely dead the wires have to be replaced as well, according to the Medtronics rep.

Take care everyone!

Hi Bonnie, and welcome to the forum!

I have been hoping someone would be able to take Prialt soon, I have a good feeling about this drug. It's made from cone snail venom and is an unbelievably powerful painkiller, but of course is only recently available, and only in the form of an intrathecal pump.

I'm sure everybody will be *very* interested in reading your journal, and very many thanks for letting us know about it. How can we read about it, is there an URL we can visit?

I do hope it proves to give you the relief you need and hope the procedures go well for you.

Hi Debbie - we've had some good threads on this, here they are:
From Mike:
http://neurotalk.psychcentral.com/sh...onotide+Prialt
http://neurotalk.psychcentral.com/sh...onotide+Prialt
From Jo:
http://neurotalk.psychcentral.com/sh...onotide+Prialt

all the very best!

[JOAN_M]

very interesting. i am always hopeful someone will find something that is safe and works! thanks for the postings on this! joan

[debbiehub]

Thanks so much for all the information- I also would love to hear more as you use this drug...

Please let us know how u r doing

Debbie

[lisashea]

All I know is that they began researching this back in 2002 or 2003. It was the newest "hope" for pain management after ketamine.
It's amazing how many years it takes for the trials to be completed and get a new drug into the market.

[jllenrad]

Ziconotide is the drug they were going to use as the trial for my pump. The difficulty was there is no accepted trial procedure for Ziconotide, and if it was used as as a first line it would have required a intrathecal trial for 5 - 7 days. So from my Doctor's practical point of view, it is necessary to do the usual 48 hour trial with Hydromorphone to determine efficacy and then add Ziconotide after implantation and titrate up while keeping the opioid at a reasonably low level.

This was the plan anyway...

[jllenrad]

News Release: February 8, 2007

Polyanalgesic Consensus Panel Issues New Guidelines for Pain Management via Intraspinal Infusion

New Algorithm Includes Ziconotide as First-Line Alternative to Opioids

CHARLESTON, W. Va.--(HSMN NewsFeed)--A panel of experts has recommended major changes to the guidelines used to determine treatment via intraspinal infusion for patients suffering from severe chronic pain. The 2007 Polyanalgesic Consensus Panel brought together a group of national leaders in chronic pain management for the purpose of updating their current algorithm. In making their new recommendations, the expert panel reviewed data published since its last meeting, as well as considered changes in FDA status and the clinical experience of the consensus panel members.

"Treating chronic pain via intraspinal drug delivery is a practice that is changing rapidly," said Timothy Deer, MD, of the Center for Pain Relief in Charleston, West Virginia. The group of nearly 20 experts was led by Deer and Samuel Hassenbusch, MD, PhD, of the University of Texas M.D. Anderson Cancer Center in Houston. The conference was held January 20 in Miami, FL.

Physicians treating patients with severe pain can now turn to increasingly sophisticated pump-and-catheter drug delivery systems. But they must choose from a growing number of novel drugs created for these systems, as well as existing drugs newly approved for intraspinal infusion. "The updated algorithm aids physicians by providing a foundation for clinical practice," Deer said.

The new algorithm includes ziconotide (PRIALT, Elan Corp.) as an alternative to first-line opioids, morphine and hydromorphone and as a second-line treatment in combination with one of the two first-line opioids. Additionally, fentanyl was moved from a fourth-line treatment option to a second-line option and clonidine was recommended for neuropathic pain as second-line single agent option. Lastly, several drugs were removed from line-four classification and designated as options only for patients receiving end-of-life care.

In previous years, the panel determined that preclinical and clinical trial data should include evidence of safety, efficacy, stability and compatibility with drug delivery systems, and, in the case of drug combinations, drug-drug stability. "The new guidelines reflect the most current and best available evidence for each of the drugs included in the algorithm -- informed, as always, by our own collective experience of their use," Deer said.

The panel's conclusions are expected to be published later this year in a peer-reviewed journal. The original guidelines were published in 2000 in the Journal of Pain and Symptom Management. The guidelines were updated in 2003 and the panel's recommendations published the next year in the same journal.

At the time of the panel's 2003 meeting, ziconotide had not received FDA approval. It became commercially available in early 2005. Ziconotide, a non-narcotic synthetic based on a conopeptide found in neurotoxic marine snails, is an important addition to the list of options physicians have to treat severe chronic pain. Unlike intraspinal opioids, ziconotide is not associated with granuloma formation. "This is a real concern because granuloma formation means you have to stop therapy and evaluate the need for catheter removal and replacement," Deer said.

The panel did, however, recognize some variability in the recommended and observed effective dosages of ziconotide. Among its recommendations will be a 0.5 to 2.4 micrograms per day starting dosage range, with a maximum of 19.2 micrograms per day. Slow dosage titration was recommended to reduce the risk for toxicities. In addition, ziconotide can be combined with other line-three treatment options (morphine or hydromorphone, bupivacaine and clonidine).

The panel removed midazolam and baclofen from line-four and neostigmine, adenosine and ketorolac from line-five due to lack of adequate clinical evidence to support their general use for chronic pain. Four drugs, midazolam, ketamine, tetracaine and droperidol were recommended only for treating patients whose prognosis is four weeks or less. Baclofen was designated for use only in patients with spasticity.

The drug options for intraspinal drug delivery to treat severe pain are increasing rapidly. Periodic update of the guidelines for their selection is therefore necessary if physicians are to make treatment decisions that will most benefit their patients, Deer said. "We must evaluate new data as it becomes available and change our selection criteria accordingly," he added.

About the Polyanalgesic Consensus Panel

The PCP is an expert panel of leading pain management physicians from throughout the United States who meet periodically to evaluate the efficiency of various treatments. Members of the 2007 Panel Include:
Timothy R. Deer, MD (The Center for Pain Relief, Charleston, WV)
Samuel Hassenbusch, MD (UT M.D. Anderson Cancer Ctr., Houston, TX)
Allen W. Burton, MD (UT M.D. Anderson Cancer Ctr., Houston, TX)
Stuart DuPen, MD (Overlake Medical Center Pain Medicine Clinic, Bellevue, WA)
Michael A. Erdek, MD (Johns Hopkins University, Baltimore, MD)
Kenneth A. Follett, MD (University of Nebraska Medical Center, Omaha, NE)
Philip S. Kim, MD (Center for Pain Medicine, Wilmington, DE)
Marc A. Huntoon, MD (Mayo Clinic, Rochester, NY)
Robert M. Levy, MD, PhD (Northwestern University, Chicago, IL)
Judith A. Paice, RN, PhD (Northwestern University Feinberg School of Medicine Chicago, IL)
Joshua P. Prager, MD, MS (Ctr. For Rehabilitation of Pain Syndromes, Los Angeles, CA)
Michael Saulino, MD, PhD (Moss Rehab Thomas Jefferson Univ. Elkins Parks, PA)
B. Todd Sitzman, MD, MPH (Advanced Pain Therapy, Forrest General Cancer Ctr., Hattiesburg, MS)
K. Dean Willis, MD (Alabama Pain Center, Huntsville, AL)
David Caraway, MD, PhD (The Center for Pain Relief Tri-State, Huntington, WV)
James C. Eisenach, MD (Wake Forest University School of Medicine, Winston-Salem, NC)
Eric Grigsby, MD (Spectrum Care Pain Treatment Ctr., Napa, CA)
Elliot Krames, MD, DABPM (Pacific Pain Treatment Centers, San Francisco, CA)
Gladstone C. McDowell, II, MD (Integrated Pain Solutions, Columbus, OH)
Sunil J. Panchal, MD (COPE Foundation, Tampa, FL)
Peter S. Staats, MD, MBA (Premier Pain/American Pain Medicine, Colts Neck, NJ)
Michael Stanton-Hicks, MD (Cleveland Clinic, Cleveland, OH)
Richard L. Rauck, MD (The Center for Clinical Research, Winston-Salem, NC)
James Rathmell, MD (MGH Pain Center, Boston, MA)
Lisa Jo Stearns, MD (Valley Cancer Pain Treatment Ctr., Division of Valley Anesthesiology Cons., Scottsdale, AZ)
Mark Wallace, MD (University of California San Diego, Center for Pain Medicine, San Diego, CA)
William D. Witt, MD (Interventional Pain Associates, Lexington, KY)
Nagy Mekhail, MD, PhD (Cleveland Clinic, Cleveland, OH)
Eric Buchser, MD (Center for Neuromodulation EHC, Morges, Switzerland)
Michael Cousins, MD (Royal North Shore Hospital, Sydney, Australia)

Hey there,

This is a bombshell of a post, overall! Thank you, Jill!

And could someone confirm I'm reading this correctly - no more ketamine to be used for treatment in Intraspinal Infusion form unless you're dying, is that right? So...no more ketamine infusions?

Or is it no more ketamine generally? - bit befuddled this morning LOL, must get my coffee!

all the best

[Bonnie1014]

So...no more ketamine infusions?

This varies depending on what you read. There are so many conflicting areas when it comes to CRPS treatment modalities. What works for one may not work for another. My pain clinic does use the Ketamine infusions and found they've been very effective. Again, you can find information everywhere. I am still reading where it is a good idea to consider a sympthectomy...lol.

This does not mean one is right and another wrong, it's just a difference of opinions. I've always stated when it comes to CRPS no one can speak in absolutes...especially those in the medical community that are treating us.

I have had the Prialt injected directly into my spine. The cathetor method was not an option for me due to Medicare restrictions on home health care. I've talked with speciailsts from all over and have been assured the best trial is one without the strong prescription pain medications. That's the term we were taught in Baltimore for the APF SPAN Leadership training. Semantics, I know, but society dictates that the term drug has a negative connotation, whereas medication is socially acceptable. We all have enough struggles without the added stigma.

Anyway, every one of them stated that the use of strong medications can be added at a later date, but initially it is best without to ensure an accurate trial. I am having the battery removed from my SCS at the same time. They are implanting my pump on April 24th!!!!!

I've been of all pain meds for a few weeks now and have seen a jump in the pain level. The Prialt certainly had an impact as once it wore off the pain skyrocketed. After having 17 blocks and none of them effective, I was leery about this procedure. Only one block was done under flouroscopy. A leading pain speciailst (not in MN) stated that should a leg go numb the block was not done correctly. I called it my Quasimoto routine each time.

Again, it is all situational and basically up to the physician and patient as to which treatment modality is right for them.

Just my opinion...

Bonnie
www.rsdsmn.org