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Through the “Valley of Death”: Dr. Pridgen, Fibromyalgia and the Looming Trials

First there were the anecdotal reports – FM patients were not just getting better but some, and not just a few, were getting well using something entirely new – an antiviral protocol, of all things, created not by a pain specialist or rheumatologist but by a surgeon.

Aside from a few doctors in the U.S., no one was treating FM with antivirals and virtually no research had examined the role of pathogens in the disease. A PubMed search of fibromyalgia and herpesviruses pulled up just two herpesvirus studies – both done over thirty years ago.

Skip Pridgen fibromyalgia

Dr. Pridgen’s hypothesis that FM is a herpesvirus disease may be put to the test by the end of this year.

But here was Skip Pridgen, a Tuscaloosa surgeon, not just asserting that herpesviruses were the cause of FM, but that an unusual antiviral protocol consisting of a herpesvirus antiviral and anti-inflammatory with antiviral properties (celecoxib) was doing the trick.  Plus, he asserted that herpes simplex virus – a virus that has gotten no attention in FM’s sister disease, chronic fatigue syndrome (ME/CFS) – was the culprit.

Pridgen, who’s treated thousands of patients with gastrointestinal issues, came up with the protocol after he noticed that his FM patients with IBS seemed to get better and then relapse. Figuring that a herpesvirus might be responsible, he gave them a herpesvirus drug and was surprised that not only their GI but also their FM symptoms improved. When celecoxib had the same effect in FM patients with arthritis, the idea of a drug combo – IMC-1 – was born.

Pridgen and Carol Duffy – his research partner at the University of Alabama – believe the drug combo is effective because each drug inhibits the virus at different points in its replication cycle and they stop viral reactivation as well.  (Hitting a virus at multiple points is a strategy employed to stop HIV.)

Pridgen created a startup Innovative Med Concepts – and put together a pretty hot team (including a past Vice President of Pfizer) and some respected researchers for its Scientific Advisory Board (including Daniel Clauw and surprise, surprise former ME/CFS researcher Dr. Dedra Buchwald) and got a Phase II clinical trial funded and going. (Dr. Buchwald was a surprise because she was so darn conservative in her approach to ME/CFS…)

The clinical trials are where it gets really serious, though. For all the reports of Pridgen helping FM patients, they mean nothing to Pridgen’s hopes of producing an FDA approved drug. The trials are where the action is, and with the recent publication of Pridgen’s Phase II clinical trial in the Journal of Pain Research, we finally have something we can really get our hands around.

The Trial

A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia. William L Pridgen, Carol Duffy, Judy F Gendreau, R Michael Gendreau. Journal of Pain Research 2017:10 451–460

Pridgen has been almost relentlessly upbeat in his assertions about the effectiveness of his new protocol and he and his co-authors don’t pull any punches in the title of their journal article which boldly states that “A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia”.

Because the trial was distributed across twelve sites, it sampled a broad array of FM patients (and doctors). With 143 patients participating, it was a good size and was double-blinded (neither the patients nor doctors/researchers knew who got the drug or placebo), placebo-controlled 16-week study.

Six questionnaires were used to assess the drug combo’s effectiveness. The primary endpoint – the test the study really had to meet involved two questionnaires – a numerical pain rating scale (NRS) and a past week functional and symptom assessment questionnaire called the Fibromyalgia Impact Quotient (FIQ-R) score.

The first part of the FIQ-R asks how difficult it was over the past week to do things like walk continuously for 20 minutes, vacuum the floor, climb one flight of stairs, go shopping etc. The second part asks each patient to rate their pain, energy, sleep, depression, etc.

The study participants had to be off a variety of drugs (duloxetine, milnacipran, pregabalin, gabapentin, sodium oxybate, and opioids). Over ninety percent of the participants were women and their average age was 49.


Functionality and Symptoms - The FM patients on the IMC-1 protocol showed a statistically significant improvement in their functionality and overall symptom scores on the FIQ-R test relative to the patients not on the protocol.  (The average patient showed a 2.2 point improvement on the eleven point scale.)  Functionality, symptoms and overall impact of FM all showed significant improvement on the drug.

Pain Assessment – Past 24 Hours – With regard to the other primary endpoint – the NSR measurement of pain, only when the data was subjected to “imputation” did the patients report statistically significant improvement in their past 24-hour pain. (Imputation analyses were used to account for missing data.)

IMC-1 was statistically significantly superior to placebo in most of the tests

IMC-1 was statistically significantly superior to placebo in most of the tests

Overall Improvement - Another test called the PGIC which asked patients about how much they had improved. Patients had to report that they were much or very improved to pass the PGIC test. About 35% of patients on the IMC-1 protocol reported they were much or very much improved at weeks 12 or 16 vs about 18% of those on placebo – a statistically significant result.

Another Pain Analysis – Responder analyses used to assess what percentage of patients received a 30-50% reduction in pain found that about 30% of FM patients reported a greater than 50% reduction in pain over the past 24 hours on the IMC-1 drug combo.

Fatigue – Two fatigue assessments (MFI, PROMIS fatigue short form) had differing results; the older MFI test showed no significant improvements in fatigue while the more recently developed PROMIS test showed that those on the drug combo received statistically significant reductions in fatigue.

Depression – The depression findings were intriguing given that one does not ordinarily link depression with herpesvirus infections. When the imputation analyses to account for missing data were performed, however, IMC-1 produced a highly statistically significant (P=0.003) reduction in depression. (This data was not in the published paper.) Since the HSV-1 virus hangs out in three different nerve ganglia in the body, knocking it down could conceivably affect many symptoms – including depression and anxiety.

Safety and Tolerability

With more patients off the drug than on the drug reporting side effects, the IMC-1 drug combo passed the safety test with flying colors. That finding was bolstered by the much higher dropout rates in the placebo arm compared to the drug arm.

The Phase II clinical trials reported on here is a proof of concept trial done to demonstrate that the drug probably works and is safe. Because these trials are also used to help manufacturers determine the best dose to use in a Phase III trial, Phase II trials are also more experimental.

The results were good but not spectacular. I asked Dr. Pridgen if he was satisfied with them. Considering that he felt that Innovative Med Concepts had a hand tied behind its back by the FDA he was:

Given that the FDA restricted our dose to that which we ultimately used, we were thrilled that we met statistical significance with our primary, secondary and even our exploratory endpoints. Being able to show statistically significant improvement in Pain, fatigue, depression, and a dramatic impact on IBS is truly unique. Honestly, I have never seen a proof of concept trial with this broad of an impact. Knowing that the recent toxicology results support our planned ideal dose, as you might imagine, we are incredibly confident in our Phase 3 trial. Dr. Pridgen

Pinpointing the Culprit

One of Pridgen’s and Duffy’s tasks includes demonstrating that herpes simplex one (HSV-1) – the virus they believe is responsible for FM – is, in fact, present. Pridgen reported that Duffy’s analysis of FM patients gut tissue is complete and that the data that emerged “far surpassed” their expectations. They are writing up the manuscript now.

Through the Valley of Death

Pridgen reported a couple of factors that may increase IMC-1’s effectiveness in the next trial. A higher dose will be used in the next trial and the screening process for the participants will be tighter to avoid the impact of confounding factors.

The huge Phase III clinical trials required for FDA approval are called the “Valley of Death” by some for good reason. Pridgen said that testing the drug combination – featuring two drugs that are already FDA approved – will require two 500-1000 person drug trials, each costing from $25-50 million. That’s on top of almost complete animal toxicology testing that’s been done and the large proof of concept Phase II trial.

Trials like that take some heavy lifting and Pridgen’s enrolled some top talent to get IMC-1 through the “Valley”. Rick Burch, the President of Innovative Med Concepts and the former Senior Vice President for Pfizer, oversaw divisions employing more than 6,500 employees and had a hand in launching Lyrica. As chief medical and safety officers, Drs. Michael and Judy Gendreau helped usher Savella to FDA approval.


Pridgen hopes to get IMC-1 through the “valley of death” and into its final clinical trials by the end of this year

Pridgen reported that Innovative Med Concepts met with 14 companies (half pharmaceutical, half companies that could provide financing) at JP Morgan in January of this year. He expects the trials to begin in late 2017.

He’s confident enough of the drug’s success to expect to employ in the next trial what he stated was the toughest primary endpoint ever used in an FM drug trial – a 50% or more reduction in pain.

Will Pridgen’s approach revolutionize our understanding and treatment of fibromyalgia? Could FM really come to be viewed as a herpesvirus induced disease – and if it is – what would that mean for chronic fatigue syndrome?

Intriguing questions all. The rubber will really meet the road for surgeon turned drug developer and the many FM patients looking for better treatment options probably at the end of this year.

 More on Dr. Pridgen and His Approach to Fibromyalgia


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  • Audrey Brimson

    March 27, 2017 at 5:21 am - Reply

    …” walk continuously for 20 minutes, vacuum the floor, climb one flight of stairs, go shopping etc. The second part asks each patient to rate their pain, energy, sleep, depression, etc.”… I have never been diagnosed with FM only ME/CFS. There is no way I can walk continuously for 20 mins, or the others, shopping not so bad as stopping frequently but exhausted on getting home, plus I do not claim to have depression. When I get a reaction there is something that happens which may be relevent, small vesicles appear on the hair line around my head and neck. I have also had many, many cold sores on my lips.Not always from being out in the sun! Thanks Cort, interesting and encouraging research for ME too..

    • Cort Johnson

      March 27, 2017 at 2:31 pm - Reply

      Hi Audrey, ME/CFS tends to be more disabling than FM. If you were to score yourself on that question you would probably give yourself the lowest score.

      Dr. Pridgen believes a similar situation occurs in ME/CFS as well and that his drug combo will work in ME/CFS. Let’s hope his FM trial is successful and he can move onto ME/CFS as well.


      March 28, 2017 at 1:01 am - Reply

      Hi Audrey, I get those little vesicles you are talking about also, I do not believe they are acne, I think they are lymphnodes…mine are in same areas you describe and along jaw neck, sometimes several on chest with a white lquidy sbstance that is different from a white head. I thave rained to be an esthetician, so I know these are NOT acne….and they seem significant to me also. Also get swollen areas in back of my head…and the headaches…..

  • Suzie

    March 27, 2017 at 12:27 pm - Reply

    This is very interesting, and seems like something we could ask a good, open-minded doctor to try. I think my neurologist might let me try a famciclovir + celecoxib combination on the back of this! I guess we’ll have to figure out dosage…
    Thank you so much Cort for such clearly communicated reporting – my fuzzy brain struggles. I don’t understand what the trials are aiming for – to get the drugs licenced as a package together and patented as a Fibro cure?

  • Jack DeWitt

    March 27, 2017 at 1:45 pm - Reply

    Our family is one that suffers from a genetic susceptibility to the spread of the Herpes Simplex virus and the havoc it can wreak throughout your body.

    For myself, all my life I’ve had the same symptoms Audrey mentions above. In addition, because the virus preoccupies my immune system, my teenage acne never cleared up until I started taking Skip’s anti-viral combo.

    And physical//mental stress seems to be a key component because I can have flare-ups in spite of the current treatment and the acne returns. But I think the higher anti-viral dosage in the Phase III trial will eliminate even that for me.

    For my wife, I believe this virus was the culprit in her uncontrollable ulcerative colitis some 25 years ago. We both believe that some environmental exposure on a family vacation triggered the disease. As a result, she suffered through a colectomy and a reconstructive J-pouch .

    In the years since, she’s suffered the onset of fibromyalgia so severe it incapacitates her. And yes, depression is a factor. On two occasions over the last ten years or so, she’s stopped her medications only to again suffer periods of incapacitation.

    But thankfully, she’s returned to the combo and pretty much fully recovered. After being on the anti-viral combo for 4-6 months, she’s moved from a 2 to an 8 on a scale of 10 on both occasions.

    As for our son (and myself to a lesser extent) mutations occurring have in the past caused worsening of the cold sore blisters. Mine are now completely gone now.

    But if my son fails to take his medication, large cold sores erupt all over his face and body, and are followed by secondary staph infections.

    I applaud Skip’s perseverance and commitment to helping push his efforts to this point. And I know it will eventually make huge differences and benefits in the lives of so many people (and their families) in the years to com.

  • Cort Johnson

    March 27, 2017 at 2:33 pm - Reply

    Really interesting Jack – thanks for sharing and good luck with your family. It’s hard to imagine that there’s not a genetic underpinning to your families problems.

  • Denise

    March 27, 2017 at 2:35 pm - Reply

    I’ve always thought there might be a correlation between herpes and fibromyalgia. If herpes can turn into shingles, perhaps it can also cause fibromyalgia.. That’s the analogy I’ve used in the past trying to explain to people that I believe fibromyalgia is viral and something “sets it off.” Stress, accidents, surgeries, etc. Keep going to try and find an answer! You’ve got 5-20 million people who would love to have their lives back!

  • aquafit

    March 28, 2017 at 1:53 am - Reply

    I’d like to put out a word of caution and food for thought for anyone who suffers from fatigue, POTS, brain fog and ANS symptoms.

    It’s been found (I think by Klimas et al) that we may have a more permeable blood/brain barrier and skin barrier and gut mucosal barrier. The other cohort which has a more permeable blood/brain barrier are those over 65 years old. The elderly now have an anticholinergic drug orotocol. What that means is that anti-cholinergic drugs are found to pass through their more permeable blood/brain barrier and CAUSE Alzheimers.

    What is an anti-cholinergic drug. Most drugs with that start with the word “anti” like anti-viral, antihistamine (1st generation like Benadryl, 2nd generation like Reactine seem fine), etc. There are also drugs with anti-cholinergic effects like Warfarin. While these drugs may work for their intended purpose, they can at the same time penetrate our various barriers and cause long term irreversible damage over time. It’s my opinion that many CFS/ME patients are bedridden due to anti-virals whereas they may have had some quality of life if they had never been given antivirals or antidepressants. I’m thinking of Whitney Dafoe, for example. He went from bad to worse after antivirals and chemotherapy.

  • Greg

    March 28, 2017 at 6:56 am - Reply

    Please correct me if my observation is off base.
    So, if HSV-1 is the primary culprit, why doesn’t this drug combo lead to a remarkable improvement in many patients rather than just a “statistically significant” improvement in some. Is it possible that the major dysfunction that is going on in our bodies allows for some of these ever present viruses to activate more often in us than the general population?
    So many millions of dollars will be happily put forth for the expectation of a successful trial that will reap many more millions of dollars for Pridgen and associates, Big Pharma, and of course Wall Street financiers. The patients (some at least) at best will have some relief from the effects of HSV-1 but mostly they will remain very ill. And of course this drug combo will have to be taken forever as I haven’t read of any expectations of this virus being wiped out. So a new drug combo to be patented (big $’s) for a chronic condition = major potential windfall for many, many years (stand back Lipitor). I can understand the enthusiasm from the invested parties. Forgive me if my enthusiasm is more subdued. Is there anything about this study that has any real chance of understanding the basic cause of our illness? Conniving business schemes to extract more money from a group long denied any serious effort for real research and answers. Somebody explain to me why my cynicism is out of place.

    • Cort Johnson

      March 28, 2017 at 1:06 pm - Reply

      Good observation Greg. If I remember correctly, Dr. Pridgen believes that an immune problem exists in FM (and ME/CFS) patients which allows HSV-1 to flourish, and yes the drug combination will have to be taken as long as that immune problem exists.

      We will see how the IMC-1 combination does in the larger trial but my guess is that if it is successful and Dr. Pridgen’s hypothesis is correct, that identifying the herpesvirus culprit will be a lot easier than identifying the immune culprit.

      I think your cynicism is out of place for two reasons: one, about 30% of FM patients in this trial received over a 50% reduction in pain. Many FM patients also received significant reductions in fatigue, mood problems and improvements in functioning. Plus, Pridgen stated that the FDA required a lower dose than he wished to use (I believe because the toxicology studies had not been finished) which suggests the next trial will be more effective.

      Consider this possibility as well: if Pridgen’s drug combo does prove to be effective and is FDI approved for fibromyalgia, hopefully that would start a hunt for the immune dysfunction present. In that case, Pridgen’s trial would have helped greatly in finding the true cause of FM. In fact, without it, given the lack of interest in the immune system in FM, one wonders how it would ever have been found otherwise.

  • Jack DeWitt

    March 28, 2017 at 12:23 pm - Reply

    Cort, I think this is a “Must See” video link to an episode of the Curiousity Series on the Discovery Channel.

    It tracks the destructive path of a common cold virus (not herpes) as it attacks healthy cells, ending after a 48 hour battle in which the virus wins.

    But the analogy is there for herpes virus–all in stunning high quality CGI animation.

    It truly enlightened me to the reality of it all. The episode is aptly named “Battlefield Cell.”

    • Cort Johnson

      March 28, 2017 at 1:06 pm - Reply

      Thanks for sharing that Jack.

  • Cynthia

    March 28, 2017 at 4:30 pm - Reply

    Hi, folks! This is exciting information for most people. However, I don’t tolerate antivirals or NSAIDS. But for others like me, I would humbly recommend L-lysine, a natural supplement you can get at your corner drug store CHEAP! You can Google the dosage and see if it helps you. I am by no means cured, but I do believe it helps me.

  • Titan

    March 28, 2017 at 7:09 pm - Reply

    Sorry to say that this is not the answer although I really wish it was. Whenever anyone is spending this amount of time and money on a solution they really want to believe the results and will skew the results either knowingly or with their own bias unknowingly. Tried this combo for about 9 months and didn’t do a darn thing. Dr. Pridgeon sure is great though. Glad there is research going on but when you hit a dead end it’s time to turn the corner to something else. We need more researchers.

    • aquafit

      March 29, 2017 at 2:18 pm - Reply

      Good to know, Titan. We have to politely ask and/or loudly demand that researchers step up instead of “do what is easy” as Dr. Ron Davis says researchers are prone to do.

      I can’t help but notice so many helps that people find link to connective tissue. L-lysine helps build collagen aand calcium mongst other things. I noticed when I attended the IACFSME conference how many patients have EDS or EDS like symptoms.

      Jack DeWitt linked to a very informative video. Something interesting about connective tissue – there’s about 28 different kinds and every symptom we have links to it. Faulty collagen can cause ATP cells to leak from adipose tissue. Bacteria is biocompatible with collagen cells. Susceptibility to viruses may be linked to the quality of our collagen. (we’re born with collagen as we’re born with a structure and organs and fluid of course, but throughout life our body makes, maintains and dissolves collagen). I’m not sure if this guy has things right as he’s a lay person who’s evaluating professional work, but please read this webpage and see if it opens up your mind to looking up some new directions to ask researchers about:

      I wonder if the researchers who found a drug which may be helpful for FOP would be helpful in collaborating with Dr. Ron Davis. Here’s a story about a person with FOP; interesting that EDSer bodies also make lumps but obviously not as hard as bone. I note the woman is fatigued – I’m sure no one’s sending her for CBT and GET! Interesting too that it’s tears and bruises that her body reacts to innapropriately by making the wrong kind of collagen (bone). I’m wondering if we don’t make faulty ATP but instead maybe we call upon our ATP reserves in our collagen (adipose tissue) when we’re doing things intensely or for a period of time and it’s been leaked out. And then when our body is called upon to repair microtears from daily activity or exercise it’s so very hard for our bodies to produce more collagen. Remember, the latest research seems to say that we don’t call on our fat energy production too soon, but rather that we call on gycolosis and fat energy production at the same time. Perhaps it’s not going for fat cells that’s the problem, perhaps it’s that the energy’s disappeared from the collagen vessel holding it?

      Not sure if this study might be related, seems so on he surface, “Mitochondrial Proton and Electron Leaks”.

      • Titan

        March 31, 2017 at 9:51 pm - Reply

        Thanks aquafit. This will take me some time to get to. I was diagnosed with Fibro/CFS for about 10 years. Problem is there is NO TEST for Fibro/CFS. Look into the work of Dr. Ritchie Shoemaker. I finally met a Dr. trained in his methods and had a positive Neuroquant MRI, was positive for MARCoNS, and my labs were all positive for what some call “biotoxin illness”. This goes by many different names, but his treatment is how I have gotten better. I still have a ways to go and have only been treating for a few months, but through the ‘Shoemaker Protocol’ I have finally been able to make some headway. I love Dr. Pridgeon, he is a great man, I just feel that this combo he’s been working on is going to lead many more people down the wrong path. I really appreciate that he is researching though. Most Dr.’s in the field Dr. Shoemaker works in have research showing over 90% of Fibro/CFS is really “biotoxin illness”. Question everything…If you suffer from symptoms of Fibro/CFS go to and you will learn how you can rule out what I talk about.

        • aquafit

          March 31, 2017 at 10:03 pm - Reply

          Thanks for the link Titan! Is that your site?

          I looked up biotoxin and sure enough, there’s research looking at it as a connective tissue disorder. In other words, in order to respond very badly to biotoxins, first our connective tissue must be compromised or damaged in some way.

          Transforming growth factor beta one (TGF b-1)- TGF b-1 is an inflammatory marker high in those with connective tissue disorders and especially prevalent in those with the 11-3-52B haplotype and those with ciguatera poisoning. High TGF beta-1 causes shortness of breath due to remodeling of lung tissue from normal, fluffy cells to fibrotic, stiff cells that have trouble taking in oxygen efficiently. TGF beta-1 also promotes autoimmunity.

          • Titan

            March 31, 2017 at 10:11 pm -

            This is Dr. Shoemaker’s site not mine. He and others have done tons of research in exactly what you say. TGFB1 is one of the many labs that can identify inflammation and exposure. In my opinion this site gives the best overall understanding of not only how one is diagnosed, but what the science is behind it and how one should treat this chronic illness. Call it Fibro/CFS/ME/Whatever, it’s all basically the same thing and Dr. Shoemaker’s success rate is real, unbiased, has been duplicated by many other Dr.’s, and is where researchers should be spending their time. Your response proves you’re light years ahead of most researchers in this field. Good luck!

  • aquafit

    March 29, 2017 at 3:06 pm - Reply

    Just had a further thought regarding the bedridden – it would be great if someone would research that anti-cholinergic drugs like antivirals and first generation antihistamines and pain relievers etc. are doing to their collagen and if it’s the reason they’ve gone from bad to worse. As CFS is considered a “central nervous system disorder” which is considered psychiatric, it’s no wonder no one has studied this as a biological disorder. t

  • Katie

    March 29, 2017 at 6:17 pm - Reply

    This is great news.Any medication that brings even 30-40% improvement on symptoms is a success!
    I’d be jumping for joy if I improved 30-40%!!!
    It’s not wasting valuable money on large expensive trials that show improvement of any disease even by 30-40%. It leads to answers, a direction at least in understanding the very complicated enigma and etiology of ME/FM

  • Greta

    April 4, 2017 at 9:01 am - Reply

    Anyone know anything about dosage?
    This make a lot of sense to me and I’d like to try it and not having to wait 5 years. :)

    • Cort Johnson

      April 4, 2017 at 9:35 pm - Reply

      I think you would have to go directly to Dr. Pridgen. He does work with other doctors…

      • Titan

        April 4, 2017 at 10:06 pm - Reply

        I know the dose, but am not sure if I am allowed to say it. I was on the higher dose that Dr. Pridgeon recommended and it did not work at all. Cort is correct, Dr. P will work with your Dr. and have them sign a non-disclosure agreement. Because my chronic illness seemed to start the day I got Epstein Barr, and because I also tested positive for the CMV and HHV6 virus’s I should have been the perfect test case. Turned out I had “biotoxin illness” the entire 10 years. Look into the work of Dr. Ritchie Shoemaker at With Fibro/CFS/ME there is no test whatsoever to show you have it. With “CIRS” you can be tested and treated. Most Dr.’s in this field believe that 90% or more of Fibro is really “CIRS” and I agree with them.

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