Antiviral Treatment IMC-1 Shows Promise in Phase 2 Fibromyalgia Trial

Antiviral Treatment IMC-1 Shows Promise in Phase 2 Fibromyalgia Trial

IMC-1, a combination treatment of two drugs targeting the herpes virus, may be a safe and effective treatment for patients with fibromyalgia, according to the results of a Phase 2 trial developed by Innovative Med Concepts.

Results were published in an article titled “A Famciclovir + Celecoxib Combination Treatment Is Safe And Efficacious In The Treatment Of Fibromyalgia” in the Journal of Pain Research.

“Infections and other stressors have been implicated in the development of fibromyalgia,” researchers wrote in their report. “We hypothesized that these stressors could result in recurrent reactivations of latent herpes virus infections, which could lead to the development of fibromyalgia. This study evaluated … IMC-1, active against suspected herpes virus reactivation and infection, for the treatment of fibromyalgia.”

The PRID-201 study (NCT01850420) enrolled 143 patients with fibromyalgia at 12 research centers in the U.S. to evaluate the effects of IMC-1 — a combination treatment of the antiviral drug famciclovir and the anti-inflammatory drug celecoxib (brand name Celebrex).

Results showed that, after 16 weeks of treatment, patients receiving IMC-1 had a decrease in fibromyalgia-associated pain compared to patients on a placebo. Half of the patients assigned to receive IMC-1 presented at least a 30% decline in pain, and 38% presented at least a 50% decrease in pain.

IMC-1 treatment also improved the scores of two questionnaires, the Patient Global Impression of Change (PGIC) and the revised disease-specific Fibromyalgia Impact Questionnaire (FIQ-R), as well as the patient’s self-reported fatigue.

IMC-1 was well-tolerated by patients. Common side effects included gastrointestinal (29% vs 42.5% in the placebo group) and nervous system (17.4% vs. 23.3%) events, but these were more frequently seen in patients in the placebo group than in those in the treatment group. Also, most patients adhered to the complete treatment compared to the placebo (82.6% vs. 60.8%).

Taken together, the results showed that suppressing latent herpes viruses may significantly improve fibromyalgia-related symptoms, and that the treatment is a safe and effective approach to reduce pain in this patient population.

Based on several positive results, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to IMC-1 in 2016 to support and accelerate the development of this therapy for those in need.

According to a press release, Innovative Med Concepts plans to conduct a Phase 3 trial using an improved IMC-1 later in 2017.

7 comments

  1. Denise Bault says:

    There are many doctors and schools of thought that believe fibromyalgia is caused by a virus. When I try to describe to people how it MAY come into being, I use the analogy of folks that had chicken pox – caused by a herpes virus – that decades later turns into shingles. I believe they may be on the right track here! Interesting study!

  2. Valerie Norton says:

    I have suffered with cold sores most of my life and the week I was hit with Fybro I remember very well. I had extreme stress at work woke up to find hands and ankles 3 times their normal size. Blood tests later showed low potassium levels but that evening my lip started to tingle so I applied my normal zovirax cream. Through the night I was uncomfortable and on waking found 9 cold sores on and around my lips. That night the pains in my body got gradually worse and have done ever since.
    Because of this I am very interested in this Trial and findings.
    I used to work as a fully trained Pharmacy Technician.

    • Tracey says:

      Hi Bonnie, I’m Tracey and a fellow sufferer. If you get cold sore, have had chickenpox, or Mono, you are a carrier of the virus. There are blood tests you can request, just ask your Doctor. The last one I mentioned is known as EBV, or Epstien Barr Virus, and most people have been exposed to it. Good luck to you.

  3. Lisa says:

    I also find fibro coincides with outbreaks of cold sores. I take Cymbalta for my fb, and it usually helps, but not always. When I have flareups it usually includes tummy aches, intenstinal gas, headaches, and terrible tendon pain.
    I find yoga helps, sometimes, and i try to do pilates, walk, playtennis, swim.

  4. Lisa says:

    Sorry, Llyisne works great to nip cold sores in the bud, taken asap at the first sign of a sore, plus massive amounts of vitimin c.

  5. Lianna Frantz says:

    I have recently been cured by Valtrex when I was treated for Shingles a few weeks ago.

    Prior to taking this medication, I have had chronic pain/burning/aching and nerve pain (felt like my nerves were on fire and would never calm down) throughout the entire left side of my body. I was diagnosed with Fibro 10 yrs ago, but no medications or therapies have worked. I also had Herpes simplex 1 (cold sores) on my lips as a teenager, and had to use Zovirax to clear it up. The chronic pain included my nose/sinuses, jaw (TMJ diagnosis), neck, shoulder, shoulder blade, spine/back, pelvic, hip, groin and knee. I also had severe fatigue, IBS, gastritis and acid reflux…and have been diagnosed with an “overactive bladder” bc I had trouble urinating and bladder pain/burning. This has been going on for at least 4 yrs, and since my mother got sick in Feb 2015, and passed away in June 2015 (I was under a great amount of stress due to this and other things going on in my life at that time) it has become unbearable and has greatly affected my everyday life.

    I have had cortisone injections, burned nerves, acupuncture, physical therapy, and have seen several chiropractors with no relief. I was recently (3 weeks ago) diagnosed with Shingles and given
    1 gram of Valtrex 3x/day. I thought it was rather odd for me to have Shingles since I’m only 46 yrs old, but I had the rash on the inside of my left breast, and my Dr was sure of it (the rash is almost gone now). About 45 mins after taking my first dose of Valtrex, the excruciating pain on my left side stopped. I’ll never forget it bc I was sitting on my couch, and all of a sudden the burning pain stopped. It was quite shocking to me since I have felt this pain 24/7 for over 4 yrs. I honestly became a little nervous that I was having an adverse reaction to the Valtrex. The next day, still no pain, I also discovered that my bladder was working properly again. I was able to urinate all the way without it stopping or it being painful (this had become normal for me prior to this).

    I’m still taking Valtrex (I’ll be cutting down to 1 gram/day in a few days), and I’m still pain free. My PCP has no explanation, and I see my Neurologist on 11/3 to discuss the results of the MRI of my brain that I just had last week (he is not aware of the recent Shingles diagnosis and that Valtrex is taking the pain away yet). I have never been so happy to have Shingles and to be pain free 🙂

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