07.25.2017

Another potential fibromyalgia drug bites the dust

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This article was originally published on NationalPainReport.com. It is being reprinted here with permission from the editor. 

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, one of three drugs under development for the treatment of fibromyalgia, didn’t adequately reduce fibro pain in recent trials. This is the second potential fibromyalgia drug to fail clinical trials within the past year. | Fed Up with Fatigue

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 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.”

Now, it’s your turn. Are you disappointed about the outcome of mirogabalin in clinical trials? Comment below! 

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Comments

  1. Jean Price says:

    I wonder how any of the new drugs being studied…for really ANY type of condition that is painful…would stack up against the common opioids medications used for many decades…that are relatively inexpensive, and with few side effects which can significantly alter the workings of the WHOLE body…like some of the anticonvulsants and antidepressants do!! I know pain medication is said not to work well for fibro and some other pain issues…yet I’m NOT SURE THAT’S TRUE FOR EVERYONE…and it looks to me like the OVERALL EFFECTIVENESS FOR REDUCING PAIN with opioids “should be” the main parameter for keeping those medicines on the market AND AVAILABLE to patients, too! Just like it is for developing these new medicines. Guess it might have to be a perfect world for this to work…like one WITH compassion…AND WITHOUT so much greed and the need to control! Sad!

  2. Nelly says:

    I’ve been using CBD sub-lingual from Green Roads Wellness, for about 4 month. It has relieved my fybromyalgia tremendously, I can function in the world again. I thought I would have to live with debilitating pain for the rest of my life. I was finally diagnosed with fybromyalgia in 2010 and have been all the few meds that are available for us. CBD has helped me, I hope it well help you. Soft hugs to all.

    • Shelley says:

      Nelly
      You sound like an advertisement for Green Roads Wellness. Are you a REAL fibro person?

  3. Given my experience with Lyrica and Cymbalta…severe depression, anxiety, weight gain, Adrenal fatigue and painful withdrawal…I would not be eager to sign up for the latest “miracle drug” until it had been in the market and proven for many years. I’m still healing my body of side effects 3 years later.

  4. Carol S. says:

    I am so disappointed. Right now I am on gabapentin 100mg. and topiramate 75mg. I started with 25mg, then 50mg, then 75mg, and then last 100mg. All doing a week each. So far my Blood pressure has been the lowest it has ever been. So far the 75mg. has helped with the pain. Gebapentin wasn’t working anymore. I have had fibromyalgia since 2011. Maybe longer. Please come up with a drug that works.

  5. Sheila Johnson says:

    It’s disappointing, but I would rather they be realistic with outcomes. I’m still very interested in trying a cousin to Lyrica as I have side effects that prevent me from giving Lyrica a real try. The sublingual cyclobenzaprine is interesting also, but I just use it for muscle spasms that won’t quit. Would be interesting to have something more effective.

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