Top Fibromyalgia Drug Tanks: One Down - Four Other Drugs On the Way

Discussion in 'Relieving Pain' started by Cort, Oct 2, 2016.

  1. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Five Drug Possibilities

    A recent report listed four drugs that are expected to be approved for fibromyalgia in the next five or so years. Adding Dr. Pridgen's antiviral/anti-inflammatory drug combo to that list gives us five new drug possibilities for FM.

    Now there are four.

    Promising Drug Fails

    Tonix Pharmaceuticals recently announced that one of the most promising drugs –TNX-102 - failed to meet its primary endpoint during a phase III trial. With that, its stock price plunged by 70% wiping out $30 million dollars in value.

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    It wasn't supposed to go like this. TNX-102 an updated form of Flexeril had been researched extensively. Eleven studies including four in fibromyalgia suggested that Tonix was really onto something. In fact, Tonix was so eager to get the drug to the market that it reportedly started the critical phase 3 before the phase 2 trial had even ended.

    It had reason to be optimistic. Tonix had reformulated Flexeril to remove a compound that was limiting the popular drug to short-term use. It repackaged the new drug in a format (sublingual) that shot the drug straight into the body, allowing a significant reduction in the dose. Phase II studies indicated the drug was safe and able to improve both sleep quality and reduce pain at the same time.

    With many FM patients not receiving significant benefits from "the big three" drugs (Lyrica, Cymbalta, and Savella) Tonix, a small pharmaceutical company, must've thought the sky was the limit.

    The Phase III trial, however, failed and it failed in the worst way possible; it failed to meet its primary endpoint – reducing pain significantly in at least 30% of the people taking it. Drugs can fail to meet their secondary endpoints without too much damage but drugs that miss their primary target are in real trouble.

    Tonix’s CEO stated that the 500 person study indicated that “TNX-102 SL showed broad beneficial effects across key fibromyalgia symptoms” as he announced Tonix was discontinuing its FM trials and turning to PTSD.

    Watching TNX-102 bite the dust was more than a bit dismaying but is not entirely surprising. It’s certainly not the first highly touted drug to get knocked out in a Phase 3 trial.

    Phase III Study Missteps Not Uncommon

    CMX-001 or Brindcifovir was a hot, hot, hot upgrade of the antiviral anti-herpesvirus drug Vistide. It, too, had been repackaged to enhance effectiveness and dramatically reduce side effects. A significant amount of research suggested the newly formatted herpesvirus drug was effective against many types of viruses leading the FDA to give it fast-track status for no less than three separate viruses.

    It, too, sailed through large Phase 2 trials and then stunk it up in the big Phase 3 trial (perhaps because of something the doctors unwittingly did.) Subsequently, Chimerix, its manufacturer, halted two more phase 3 trials. The company is sticking with one Phase 3 trial but is going back to the drawing board and re-embarking on more Phase 2 trials. Brincidofovir was considered by many to be a drug that could not fail.

    Likewise, in ME/CFS the phase II Synergy trial combining methylphenidate and mitochondrial nutrients seemed to be a lock before it, too, failed to meet its primary endpoint. The unusually high placebo effects suggested there may be quite a few ways to fail a clinical trial.

    Brincidofovir and Chimerix are still around, but the same might not be true for TNX-102 and Tonix. Tonix hoped to move forward with PTSD trials, but the company's huge stock price plummet and the need to raise a large amount of money for PTSD trials makes that possibility unlikely.

    It would be a shame to lose this drug entirely. A successful PTSD trial would make TNX-102 - which surely must help some FM patients - available off-label.

    It's a tough world out there in the drug approval business.

    One Down – Four to Go.

    Meanwhile, we have at least four more drug possibilities exist.

    Mirogabalin

    Tonix apparently went all in on its 500 person TNX-102 trial, but the Mirogabalin trial is something else. Produced by the huge Japanese pharmaceutical company, Daiichi Sankyo, the FM mirogabalin trial numbers no less than 1,000 participants.

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    Mirogabalin, a calcium channel blocker, is the latest attempt by a pharmaceutical company to capitalize on the Neurontin / Lyrica line of drugs. Mirogabalin’s big potential plus is its ability to stop the transmission of pain signals without producing the side effects seen in Lyrica. It's able to do this by selectively binding to a particular section of the calcium channels that transmit pain.

    Considerably lower dropout rates in the 450 person phase II trial mirogabalin (18%) than for Lyrica (27%) suggest Daiichi Sankyo may be onto something. Completion of the drug trial, which is filled up, is expected in March 2017.

    Time-Release Form of Lyrica and TD-9855

    Two other possibilities are a time-release formulation of Lyrica, and TD-9855, a norepinephrine serotonin and reuptake inhibitor. The time release form of Lyrica would add some convenience but not much more, and the history of NSRI’s in FM is not particularly encouraging. Plus no T-9855 Phase III trials are under way.

    Pridgen’s Antiviral Approach To Fibromyalgia

    Dr. Pridgen’s novel approach to fibromyalgia involving an antiviral drug (Famvir) and an anti-inflammatory drug with antiviral properties (Celebrex) could upend decades of thinking on FM. The Phase 2 trial was moderately successful, but Pridgen believes the next trial using better dosing will get better results. Pridgen’s currently raising funds for a Phase 3 trial. Check out an Oct. 2016 update on Dr. Pridgen's progress here.

    Other Possibilities

    These drugs present just some of the possibilities that may become available in the next four or five years. People with FM can benefit from drugs not approved for FM and other pain drugs are being assessed. Plus non-drug trials including several brain stimulation trials, a trial using the Bemer device, a passive heating trial and others are underway in FM.
     
    Last edited: Jul 7, 2017
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  2. fdotx

    fdotx Well-Known Member

    Speaking of Pridgen's anti-viral approach, I received a wonderful response from Dr. Teitelbaum re when he uses them, percentage of population who have high titters to the various viruses etc. ( really don't understand the criticism he gets) but then Dr. Naviaux's opinion about them came out so I quit taking mine - has anyone else on the forum discontinued theirs and I wonder, if there is benefit to FM symptoms, would those folks run the risk of damaging their mitochondria and going into CFS? I realize this damage isn't proven but certainly does give pause, especially being the concern of a scientist such as Dr. Naviaux.
     
  3. Steve

    Steve Active Member

    Idk if anyone who took cyclobenzaprine (Flexeril) would ever think the zombie drug could be re engineered to work.

    Keep in mind, they set a high bar for that trial and the Mirogabalin trial (if I recall correctly) to get into the studies, making you get off pain meds and sleep meds. How bad is your FM pain and insomnia if you can ditch them both for 13 weeks, maybe of placebo even? I couldn't and declined both studies. Even if they worked, I'd be wondering if they got folks with mild FM in the study.

    As for Teitelbaum, I could barely get through his book I thought it was such unfounded crap.
     
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  4. fdotx

    fdotx Well-Known Member

    Hi Steve, the aclovir wasn't helping and was about to try Famvir when the concern of mitochondrial damage was brought up. But you're right and maybe I'll reconsider.....
     
  5. fdotx

    fdotx Well-Known Member

    Sorry, I meant to reply to Strike Me Lucky
     
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  6. M.k Bunch

    M.k Bunch New Member

    I have been on flexed I'll for many years and it does help with the painn, just not sure if it is enough to attribute it to FMS help






    QUOTE="Steve, post: 24948, member: 110"]Idk if anyone who took cyclobenzaprine (Flexeril) would ever think the zombie drug could be re engineered to work.

    Keep in mind, they set a high bar for that trial and the Mirogabalin trial (if I recall correctly) to get into the studies, making you get off pain meds and sleep meds. How bad is your FM pain and insomnia if you can ditch them both for 13 weeks, maybe of placebo even? I couldn't and declined both studies. Even if they worked, I'd be wondering if they got folks with mild FM in the study.

    As for Teitelbaum, I could barely get through his book I thought it was such unfounded crap.[/QUOTE]
     
  7. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    It sounds like you should definitely be on them. I think they suggested that unless people have a PCR positive test to think about not trying them. I think that's a bit difficult - I don't know how many people have access to that test (?) and from what I've heard the pathogens can show up irregularly in them as well.

    My guess is trial and error informed by testing - as poor as it is - is the best guide.
     
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  8. Kat

    Kat Member

    It would be nice to start seeing drug trials that include all the "omic" data for participants so we get a better picture of the differences between responders and non-responders. It would really suck if stage III trials keep failing simply due to the heterogeneous nature of illnesses!
     
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  9. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Isn't that the truth!
     
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  10. Debbie Joseph

    Debbie Joseph New Member

    Thanks for this article on drugs in the pipeline. I'm glad to see you have included Dr. Pridgen's protocol too, even though it is decidedly different from the other drugs in its approach. I have been a patient of Dr. Pridgen's for almost a year, and have been on his regimen of famvir/celebrex (and the other drugs he prescribes) since last November. I have seen improvement at nearly 100% in the pain, fatigue and sleep issues of my 25 year battle with fibromyalgia. It has not been a smooth journey and drugs needed to be tweaked along the way. But I am now at the point where I have begun slowly building strength back with yoga and a gentle core strengthening process---this would have been completely impossible a year ago for me. I had previously tried lyrica, cymbalta, savella, LDN, guaifenesin, and a host of others with disappointing results. I pray that Pridgen's protocol makes it through phase III trials and comes to market; I want every person fighting the fibro battle to have the chance to get their life back as I have!
     
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  11. Remy

    Remy Administrator

    Great news about your recovery progress! And welcome to the forums...
     
  12. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Thanks Debbie for sharing this and congratulations! I hope you make it all the way back to health and can include your recovery story in our recovery stories section. Good luck!
     
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