Another Potential Fibromyalgia Drug Bites the Dust

Another Potential Fibromyalgia Drug Bites the Dust

By Donna Gregory Burch.

The fibromyalgia community suffered yet another disappointment earlier this month when drugmaker Daiichi Sankyo announced mirogabalin, a potential new treatment, failed to meet its pain-reducing goals in clinical trials.

Last year, I reported that three potential new fibromyalgia drugs were heading to clinical trials. Two of those contenders – mirogabalin and TNX-102, a sublingual form of cyclobenzaprine, have now been shown to be ineffective for fibromyalgia. The third drug – an antiviral/anti-inflammatory combo named IMC-1 – will likely head to trial later this year.

Mirogabalin is a cousin of Lyrica, the first drug ever approved to treat fibromyalgia, but it was supposed to work better than Lyrica with fewer side effects. Unfortunately, mirogabalin didn’t live up to those claims.

“In the three, 13-week, double-blind, global, phase 3 ALDAY clinical trials evaluating mirogabalin for the treatment of pain associated with fibromyalgia, mirogabalin did not meet the primary efficacy endpoint to demonstrate a statistically significant reduction in the weekly average of worst daily pain score from baseline to week 13,” reads a Daiichi Sankyo press release.

The ALDAY trials involved more than 3,600 patients, ages 18 and older, from about 300 centers throughout North America, South America, Eastern Europe, Western Europe and the Asia Pacific region.

As blogger Cort Johnson summarized, “Daiichi Sankyo bet big, big money that its safer, more effective version of Lyrica called mirogabalin was going to be the next big thing in fibromyalgia. … They had good reason to be confident. Lyrica, mirogabalin’s predecessor, binds to a calcium channel subunit that has pain reducing and central nervous system effects. Those central nervous system effects are believed to cause its rather notorious side effects. Mirogabalin, on the other hand, binds to a calcium channel subunit believed to have strictly analgesic; i.e. pain reducing effects. In one fell swoop, Daiichi was going to produce a drug that was not only more effective but had fewer side effects and was longer-acting than Lyrica.”

But alas, fibromyalgia’s notoriously difficult-to-treat pain was too much for mirogabalin to handle. Despite its failure in fibromyalgia-related trials, Daiichi is not ready to concede defeat. When asked last week about the future of mirogabalin as a fibromyalgia treatment, spokesperson Alyssa Dargento said, “It is premature to comment on the regulatory submission plans for mirogabalin in the U.S.”

Asked if there will be future mirogabalin/fibromyalgia trials, she said, “At this time, the global clinical development program for mirogabalin consists of several phase 3 clinical trials, including NEUCOURSE [for post-herpetic neuralgia], REDUCER [for diabetic peripheral neuropathic pain] and ALDAY [for fibromyalgia pain]. The results from the global clinical development program will guide our path forward for mirogabalin.”

While mirogabalin didn’t meet pain-relieving goals for fibromyalgia, it did successfully reduce the weekly average daily pain score in patients with post-herpetic neuralgia in the NEUCOURSE trial.

With two of the three potential fibromyalgia drugs in limbo, the fibro community’s attention now shifts to IMC-1, a combination of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, being developed by Alabama general surgeon Dr. William “Skip” Pridgen and his company, Innovative Med Concepts. Pridgen and his research team believe the herpes simplex virus may be an underlying cause for fibromyalgia symptoms. He’s been treating fibro patients with his own version of IMC-1 for several years with promising results.

When asked last week for an update on IMC-1, Pridgen said, “[Innovative Med Concepts] has been spending the last six months finishing pill design/testing and completing needed toxicology studies, thus readying itself for the End of Phase 2 FDA Meeting. Additionally, we are in discussions with several pharmaceutical companies about a strategic partnership moving forward. We are still hoping to begin the first phase 3 trial this winter.”

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com. You can also find her on Facebook and Twitter. Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.

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Authored by: Donna Gregory Burch

There are 11 comments for this article
  1. Maureen at 7:27 am

    Hi Donna,
    Thank you for reporting this info and for all of your hard research that you do without end, on our behalf. I am always grateful for you.
    As I’ve told you in the past, well over a year ago, when you first reported Dr. Pridgen’s work/IMC-1 it all made sense to me.
    So I went to my primary doc and had him put me on both meds (antiviral and Celebrex). I had had several Shingles flares in the past 2 years and my daily spine /body pain and fatigue was off the charts for a long time.
    The ‘daily’ Celebrex proved to raise my B/P so I now only take one on occassion on really bad days (it doesn’t raise my B/P with just one now and then and it does help my pain from the body inflammation) and the antiviral has kept me from any Shingles outbreak, for which I am ecstatic!
    With that said… my FM went haywire in the past 2.5 mths!!!
    The extreme fatigue was horrific for many weeks, I could barley lift my head off the pillow, let alone get out of bed. I live alone, my life shut down, and it was extremely difficult for me.
    And then, for some odd reason (praise GOD!) it lifted last week.
    Although, I remain ‘just tired’ and sensitive to activity.
    I live in Florida (almost 3yrs) and apparently the summer heat/humidity can be the blame for waking up the virus within me.
    The is my 3rd summer with this and I never ever had long flares like this before I moved to this state. My research confirms the reasons why. I may have to move again.
    Regardless, I do look forward to the combined med to be available to try.
    I’d like to add…when the burning body pain rears its’ ugly head…drinking water soluble CBD oil greatly helped it.
    Keep up the great work!!

  2. StevefromMA at 5:36 am

    Time will tell about Pridgeon. Beating placebo is a high bar and the FDA has allowed hundreds of meds with tiny efficacy and scary toxicity to be licensed. You have to read the original research to see if you are raising your risk of death by 20% and chance of improvement by 1% above placebo. As someone noted, Big Pharmacy is in business to make money and they will cynically LIE and DISTORT to do so until caught. Brain inflammation is talso he hypothesis for the vaccine I’ll be getting but there are no guarantees. This is a complex disorder with minuscule funding and largely, also as noted, recycled and repackaged old meds. GLTA.

  3. John S at 5:39 pm

    Another shocker ! Up soon is Cyclobenzaprine Film; is it magic ?

    Finding a replacement for what works could prove to be a Fools journey.

    If they ever do find a replacement I’m sure the side effects will be worse than the pain.

    Good luck & Gods speed !

    Thanks,

    John S

  4. Liz Hall at 3:36 pm

    Carol, there are 8 viruses that fall under the herpes umbrella, and include the common cold sores and genital herpes that many think of first, but also chickenpox, shingles, Epstein-Barr virus, mononucleosis, and others. They are incredibly common in adult populations and it’s entirely possible that someone can contract one without showing outward symptoms. I wouldn’t be so quick to dismiss the possibility.

  5. Liz Hall at 3:29 pm

    Alanna, it is my understanding that Celebrex was used because it crosses the blood/brain barrier, whereas more common NSAIDs do not. Inflammation in the brain is now suspected to be a component to fibromyalgia, and may explain why none of the currently approved medications work very well to treat it.

    A statistically very small increase in the chance of a heart attack vs. the possibility of a life without disability is well within acceptable risk parameters for many of us who have been robbed of our quality of life by this condition…

  6. Kim Leonoudakis at 11:43 am

    Fibromyalgia is caused my Lyme and co-infections. Stop making drugs to mask symptoms and treat the underlying cause. Her bio even says she has Lyme. We need more accurate testing for Lyme because millions are misdiagnosed. It’s all about drug companies making money . Greed-greed-greed.

  7. Kathy C at 9:37 am

    It looks like they are “Researching Drugs’ or Combinations of Drugs that are already on the Market. Repackaging these is a very profitable and streamlined process. With so any Industry Insiders and loosened Regulations, these Medications don’t have to be very effective for them to end up on the Market. Pridgen’s work sounded interesting, at least he was working on an alternative theory, but we have not heard much about his “Cure.” There most certainly would be Anecdotal Evidence if his “Treatment” were effective. Physicians could most certainly Prescribe this or a similar drug combination to their patients now, apparently it is not that “effective.”
    With so many Pharma Insiders now on Regulatory Boards and the push for increased Profits, and “Streamlining,” These Medication will be Profitable whether they work or not. They will cash in on the “Opiate Epidemic” too, Physicians will be happy to prescribe these instead of Pain Medications, for Off Label use, as long as they get people to believe they might work. The Pharma Industry no longer relies on Innovation and Research, they don’t have to a good Marketing Plan and prepackaging are more profitable. The Media will hype them anyway.

  8. Carol at 7:04 am

    Pridgen and his research team believe the herpes simplex virus may be an underlying cause for fibromyalgia symptoms.

    I’ve had FM since 1985, never have I had a herpes virus!. I doubt that this has anything to do with this virus.

  9. Stephen Golder at 6:09 am

    There are almost as many FM theories as patients, always a bad sign. I hope the trial I’ll be in is the right one.

  10. Alanna Wilgus at 5:11 am

    I wonder why, of all the non-steroidal anti-inflammatory drugs available, they chose Celebrex to combine with the anti-viral drug. It was almost taken off the market in 2005 due to it’s black box warning warning that it increases heart attacks. I wouldn’t take it on a bet.

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