Trial Shows Positive Results for Treatment for Fibromyalgia

Trial Shows Positive Results for Treatment for Fibromyalgia

By Staff

Editor’s note: Last May, National Pain Report ran an article by Donna Gregory Burch, about the pairing of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, and it’s success in Phase 2 trials for the treatment of fibromyalgia. The combo, known as IMC-1, was billed as the next blockbuster fibromyalgia drug, with the potential to challenge the likes of Lyrica and Cymbalta, two of the most profitable drugs prescribed for fibromyalgia.

On March 7th, in a PR Newswire press release, Innovative Med Concepts announced that the Journal of Pain Research published the results of Phase 2 PRID-201 trial using IMC-1 for the treatment of fibromyalgia (Journal of Pain Research 2017:10 451-460).

The 16 week study was conducted at 12 research centers with 143 fibromyalgia patients.

According to the press release, “The PRID-201 study demonstrated that patients randomized to IMC-1 (celecoxib+famciclovir) experienced a significant decrease in fibromyalgia-related pain vs patients randomized to placebo.  Over 50% of the IMC-1 patients had at least a 30% reduction of pain and 38% of them achieved at least a 50% reduction in pain during the study. Patient global impression of change (PGIC) and the revised disease specific fibromyalgia impact questionnaire (FIQ-R) response rates were also significantly improved.  Additionally, IMC-1 significantly improved self-reported fatigue, as measured by the NIH developed PROMIS fatigue inventory.  Essentially all primary endpoints and most of the secondary endpoints met statistical significance in the PRID201 Trial.”

Phase 2 results show slightly better results than Cymbalta, the most effective of the three FDA-approved fibromyalgia drugs (Lyrica, Cymbalta, and Savella).

Side effects were low, with more patients from the placebo group dropping out of the trial due to adverse reactions than those taking IMC-1.

“The results of this study suggest that IMC-1 is safe and efficacious in the treatment of the symptoms of fibromyalgia.  Based on a novel mechanism of action and the study results showing efficacy on a range of important outcome measures, improved retention rates, decreased adverse event rates, IMC-1 may represent an effective and differentiated treatment for fibromyalgia sufferers.”

The results of this Phase 2 trial are significant in that the FDA has granted IMC-1 fast track status, with IMC planning to start a Phase 3 study with an “improved IMC-1” this year.

Click here to read the full PR Newswire press release.

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Authored by: Staff

There are 9 comments for this article
  1. Jill Tanner at 10:54 am

    I had brain surgery in 2011 and since that I have had non stop migraine. I have been in and out of the hospitals, back and forth to different doctors trying to help me. My body hurt in different places but none of them worried about that, just my head. Finally a new head doctor checked my whole body out and diagnosed me with fibromyalgia. I don’t do narcotics for my pain, and none of the migraine meds work on me. So that means I am in pain all day every day. In November I had a blackout which is normal for me 🙁 and I fell on my right hip, it started to really hurt, ended up having MRI on it and it looked fine. Now my left hip is killing me. I am wondering if I am like you Kelly Branscom and have bursitis. I can’t do any exercise because of my head, I try to do yoga but it kills my hips. What am I supposed to do? I think the doctors get sick of me.

  2. Kelly Branscom at 4:18 pm

    I was diagnosed with fibromyalgia at the age of 27 I am now 54 I suffer in pain constantly a heating pad is all I found works I take 60 milligrams of Cymbalta for the last 11 years why I really feel that this disease or this inflammation disease should be researched to the fullest extent because we are suffering needlessly I also suffer from depression severely I had electric shock last year 12 treatments is there any research on severe depression and fibromyalgia oh how can I forget I also have bursitis of the hips I lost 35 pounds I’ve kept it off but I still suffer daily my pain level is a 7.5 no less aspirin aspirin aspirin 4 times a day Neurontin Gabapentin 800 milligrams twice a day I live in Center City Philadelphia Pennsylvania

  3. Sheryl Donnell at 1:34 pm

    I am afraid this is just another fast tracked very expensive way to rebrand 2 generic drugs that haven’t been properly tested. Celebrate is known for Cardiac problems…what happens to us adding the anti-viral? Would the anti-viral with an opiate work better?

  4. MichaelL at 9:23 am

    Taking daily NSAID-s have been reported to increase heart related deaths. One study recently warned of it occurring in people taking them for viral diseases. I try to avoid taking them daily, even though I get some relief from my arthritic joints. My neuropathy does not respond.The Tramadol has minimal effect on it, too. But, God forbid, my asking for anything stronger!

    I even remember a doctor prescribing my patient, a nurse allergic to Ibuprofen, that exact drug! She did not have it filled. Where else would a patient be given a drug that could giver her anaphylactic shock and kill her?! And this is acceptable behavior?! People, stay away from doctors as much as you can! They seem to be getting less concerned about us, and more about their incomes!

  5. Maureen at 8:31 am

    I’ve been aware of this combo coming down the pike and will be watching for its’ release.
    When Donna posted that info last year I spoke with my primary doc and we decided to try celebrex and acyclovir.
    Well, the ‘daily’ celebrex raised my B/P so now I only take it on really bad joint/muscle pain days, but I’ve maintained on the antiviral daily for a year now and I have not had a single ‘bad’ episode with my CFS since.
    I was having 7-10day (in bed with extreme fatigue) episodes each month for a long time at that point. My CFS is mostly triggered by stress.
    The stress of living in moderate/severe pain (with my spinal issues alone) and what the gov’t and doctors are doing to us rules my body every day!
    So I was constantly having episodes of heightened body pain and fatigue and breakouts with Shingles. The antiviral has calmed all of that down considerably and I am grateful for that. If my CFS is triggered…I’m only in bed now for a day or two.
    Regardless, I still suffer in great pain and my doc plans to decrease my pain med next week. Pray pray pray for help!

  6. Jillian Drexler at 10:38 pm

    Sounds promising. I’d like to try it, as Cymbalta & Lyrica didn’t work for me.

  7. connie at 11:34 am

    They can study various drugs from now until hell freezes over but when a patient has been successfully using a particular drug or combination of drugs for years with success they shouldn’t be forced to step back into horrible pain just to try other drugs that may or may not work just because of some study. If it’s not broken don’t fix it!

  8. Lee at 9:10 am

    How does it work on those who are unable to take NSAID’s?

  9. TiredOfPaindue2USA at 8:36 am

    This is great but some dicyors from personal experience have been using this and like combination for 7 plus years. The downfall is for patients like myself that hope for alternative therapies but are highly allergic to the active ingredients like sulphates, sulfates and other common drugs used.
    I’m even having problems recently with the standard percocet since tge government has allowed the US pharmaceutical companies like Rhodes, Activas and Amneal (all generic to Endocet) to produce synthetic fillers rather than the active ingredient oxycodone making me sick. I’m going to wrap up with I fear what’s going to happen and that is all the medication that works being pulled for these new hack job medicines. Very frustrating. Please research everything you can before trying these new combos, don’t be hospitalized like myself. Gentle Hugs.

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