This article was originally published on Prohealth.com and is being reprinted here with permission from the editor.
I’ve never had much luck with big pharma’s solutions for fibromyalgia, but I know plenty of fibro warriors whose lives are improved by medications like Lyrica, Cymbalta, Savella, gabapentin and others.
We all wish for that magic pill, so it’s a big deal when pharmaceutical companies announce they’re testing out potential drugs for fibromyalgia.
After all, we are way overdue for new pharmacological treatments. It’s been more than a decade since the U.S. Food & Drug Administration (FDA) approved its last drug for the treatment of fibromyalgia, Savella. That statistic right there is proof of just how perplexing fibromyalgia is for both patients and the pharmaceutical industry.
But four companies are up to the challenge of figuring out the mystery of fibromyalgia and are in the midst of trying to develop new pharmacological options for patients. If successful, several new drugs may hit the market in coming years.
NYX-2925
Last June, Aptinyx Inc. announced positive results from a 23-patient, phase 2 study of its novel NMDA receptor modulator, NYX-2925. During the single-blind, placebo-controlled, sequential-designed study, advanced imaging techniques found statistically significant improvements in brain activity biomarkers for central pain processing. Patient-reported pain and other symptom scores were also promising.
According to a press release, there were no serious adverse events reported during the study, and the drug was well tolerated by patients.
“The statistically significant effects on both pain-related brain activity and patient-reported clinical measures elegantly demonstrates that NYX-2925 is acting in the brain to alter pain processing, leading to pain alleviation,” says Norbert Riedel, Ph.D., Aptinyx’s president and CEO. “The results of this study reinforce what we observed in patients with advanced painful diabetic peripheral neuropathy (DPN) in our recent phase 2 DPN study in which NYX-2925 greatly alleviated the centralized pain that is predominant in these patients. The consistency of these data confirms our confidence in advancing NYX-2925 as a treatment for chronic pain.”
Aptinyx plans to recruit fibromyalgia patients for a larger 12-week, randomized, placebo-controlled study of NYX-2925 later this year.
IMC-1
Update 7/7/21: Last month, Virios Therapeutics, the biotech company now overseeing the development of IMC-1, announced that its phase 2 trial of IMC-1 has begun. Read the full update here.
The FDA fast tracked IMC-1, a combination of famciclovir, a common antiviral, and celecoxib, an anti-inflammatory arthritis drug, in early 2016 for a phase 3 trial, but progress has moved at a slug’s pace since then.
For the past two and a half years, IMC-1 has undergone animal studies as required by the FDA to determine potential toxicity.
IMC-1’s parent company Innovative Med Concepts is seeking $30 million from investors to fund the phase 3 human study. If successful, the trial should start early next year, according to Dr. William “Skip” Pridgen, the drug combo’s discoverer.
As a gastrointestinal surgeon, Pridgen is an unlikely source for the next blockbuster fibromyalgia drug. However, his drug combo of an antiviral and an anti-inflammatory addresses a theory that many in the fibromyalgia community have suspected for a long time: Fibromyalgia could be caused by some sort of underlying infection.
In Pridgen’s case, he believes fibromyalgia is triggered by the herpes simplex virus (HSV). IMC-1 works by combining famciclovir and celecoxib, both of which have antiviral properties, to suppress HSV.
(This article gives a more detailed explanation of Pridgen’s theory about the connection between HSV and fibromyalgia.)
Pridgen says he’s successfully used the drug combo in his Tuscaloosa, Alabama, medical practice for years now.
“We’ve treated thousands of patients with this protocol, and every single day I get to witness exactly what this medication does,” Pridgen says. “Once you suppress the virus, it takes [about 12 to 14 weeks] for the immune system to reset and for the body to feel normal. We’re seeing about 90 percent of the patients will get 85 percent better if they follow the protocol precisely.”
Next year’s trial is anticipated to involve between 250 to 500 patients at up to 50 sites around the country.
TNX-102 SL
In 1975, one of the pioneers of fibromyalgia research, Dr. Harvey Moldofsky, was able to induce fibromyalgia-like symptoms in healthy college students by depriving them of deep sleep for several nights. He concluded fibromyalgia (called “fibrositis” back then) should be considered a “non-restorative sleep syndrome.”
That research was some of the early inspiration for TNX-102 SL, a low-dose sublingual version of cyclobenzaprine developed by Tonix Pharmaceuticals Holding Corp. Cyclobenzaprine, sold under the brand name Flexeril, is a commonly used muscle relaxer and sometimes prescribed off label as a treatment for fibromyalgia.
“We think the best way to understand how our drug [TNX-102 SL] is working is by improving sleep quality,” says Dr. Seth Lederman, CEO of Tonix. “Sleep quantity is something that is delivered by Ambien or Lunesta or some of the benzos like Klonopin, but the difference is those drugs … tend to be injurious of high quality sleep. What’s distinctive with our drug and our treatment protocol is we think this medicine improves sleep quality and doesn’t get in the way of some important [activities] that your brain does at night when you’re sleeping.”
Tonix has run into some issues with bringing TNX-102 SL to market for fibromyalgia. TNX-102 SL did not meet its pain-relieving goal in two previous trials when administered to fibromyalgia patients at a dose of 2.8 mg. It seemed like TNX-102 SL was destined for failure like so many other potential fibro drugs before it, but Tonix became hopeful again after a trial of patients with post-traumatic stress disorder reported good results when taking TNX-102 SL at 5.6 mg.
Last April, Tonix was able to get FDA approval to move ahead with a new phase 3 study this fall in which TNX-102 SL will again be administered to fibromyalgia patients – but this time, at a dose of 5.6 mg.
“We did two studies with a dose of 2.8 mg, and in both of those studies, we saw very encouraging evidence across the board,” Lederman says. “We saw it in the daily pain score. We saw it in the Fibromyalgia Impact Questionnaire. We saw it in other measures of fibromyalgia, and in both cases, we narrowly missed the primary endpoint. We think with twice the dose, we’ve got a good shot of getting a better result.”
This fall’s trial is expected to enroll around 500 patients at about 25 sites around the United States.
ASP0819
There’s very little that’s known about Astellas Pharma’s fibromyalgia drug ASP0819 other than the company completed a phase 2, placebo-controlled study last year involving 186 patients. No results or other details have been posted yet on ClinicalTrials.gov.
When asked for more information, Astellas spokesperson Stefanie Prodouz provided the following statement: “ASP0819 is in phase 2 development as an investigational therapy for the treatment of fibromyalgia. We are currently analyzing existing data to determine next steps for the program.”
Now it’s your turn: Are you excited about any of these potential treatments? Share in the comments!
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I’m Donna, a longtime newspaper reporter, health writer and chronic illness thriver! Fed Up with Fatigue provides weekly news, research, treatments and more to help you live better with fibromyalgia and/or Lyme.
My fibromyalgia has become unbearable . I am no longer able to cook or do other household tasks. I cannot walk without a cane or walker. I have become more and more depressed. I have been on several antidepressants and muscle relaxers with very little success and some miserable side effects. How can I get into some of these new medication studies. I am ready to try anything!
I would go to ClinicalTrials.gov and use that site’s search feature to search for fibromyalgia studies.
I get lots of calls for these studies.
I never qualify!
Reason? You have to get off all meds to participate!
Can’t do it.
It sounds like they are recycling drugs we have already used. Flexeril was the first drug prescribed to me 25 years ago when I was diagnosed with Fibromyalgia. Although very promising, it seems like we can already get Celebrex and Aclovir from our doctor now. But it would be nice for it to be approved as standard treatment instead of hunting for an “out of the box” doctor to prescribe it.
With all the world hit by Covid, I expect Fibromyalgia and Lyme will be on a back burner at this stage. Here in Australia we’re still waiting for high grade medical CBD oil to get to us.
I’m 59 now and was diagnosed in 2009-2010, that was because I asked my new GP about the strange numb spots that were spreading over my body. I’d already been told I had Chronic Depression & BPD.
But this doc looked at my blood work which I had reems of, to rule out diabetes. Now I’ve spent my whole life suffering from viral infections starting off with bad Cholic moving through colds, flu, bronchitis, tonsillitis, chicken pox, rubella and yes I had all the shots! Cold-sores the bane of my life and even managed Neutropinia and Hep C (yes the treatment worked, no damage) soooo…basically I am a walking textbook case from childhood! No measles either, go figure!
Thing is this doc looked at all my numbers just like the 10 other ones before him. But he saw where the numbers the were supposed to read 0 read 640 & I’m off to see an immunologist & a neurologist and a battery of tests I’d never had before.
Guess what I had Fibromyalgia primary & Sojgrens primary + BPD and Depression. Turns out wasn’t just imagining it all!!
So since then the amount of drugs I’ve had to try pretty much covers all of it. I also have immunity to a massive range of them. They don’t work or I have really bad side effects & they don’t do anything but make it worse!!! So now I have a routine course of drugs that help keep me sane, not upright or able to do much, but pretty sane. It’s Efexor, Plaquinil, Vit D, Paracetamol, Mizart, and at night Stilnox and Valium. Also Claratyne when I get the itchy patches!… So as far as I know nobody in Australia is doing any research at all and like I said, we have to wait and jump through hoops for the hope of being put on CBD so we can stop taking all the others that are slowly destroying our insides. And I’m still explaining to friends that exercise can truly hurt not help. My doc actually laughed and patted my shoulder gently when I asked as I’m heading to 60 if I should get a stress test. He said, “Oh Betsy you have to be able to have a stress test to take one!” Yep living the life!!!😆😆
Hi B ! I have tried cbd , mj, venlafaxine,gabapentin and a dew more with no success . The happy pills made me not care too much that i hurt but after several years even they quit . I’m not able to do much of anything . But i can read !! My best to you, hope for less pain . Leslie
Hi it’s a bummer have fibromyalgia but I have CBD to help. I order it from Kent it’s very good. I wouldn’t be with out anymore. Send away for it to try. Good luck take care xx
Are you having any luck with the drug trial we are on from Doctor in Europe? I had laser surgery on my neck and got a rare side effect. My body sent pain waves around the front of my shoulder and up the back of my scalp. Now I am on Medrol. Pack for those symptoms. Also have had bladder problems. I have herpes too and was wondering if that has any impact on fibro. My pain is manageable but I feel fatigued but not just tired but hard to stand up. I use a cane all the time now.
I’ve read that having ketamine infusions are saving lives as break- through for ppl with a history treatment resistant depression but it is also is being used to treat fibromyalgia.It’s an FDA approved treatment.There’s a new perscription drug thats a ketamine nasal spray as another option besides in-office infusions. So far,unfortunately,Medicare and most insurances don’t cover the treatment.It’s around $2thousand but it be worth it to try due to its positive effects.I can’t afford it but if you can its worth checking out imo.
I did Ketamine infusion treatments for three months for my fibromyalgia. Yes it made a world of difference however being slave to the 2 to 4 hour treatments every 2 to 3 weeks became unbearable. I was also told my insurance was going to cover and after three months I incurred a $12,000 bill. And that was after insurance. I don’t think they’re where they need to be yet with that. I know they approve the nasal spray but have not yet found a doctor that would prescribe that for my Fibro since I’m not suicidal
I am so very excited to hear there’s activity in this direction. At times I feel I cannot stand another minute of this. I have been treated as having fibro for years. I had it long before any actual diagnosis. I am wary of having to stop my regimen to begin a new one…that is what bothers me. I feel that badly. I once was such a vibrant person.
I am so frustrated, !! I am from South Dakota and to get a doctors help!!! Is one of the most stressful most irritating most impossible thing to deal with so I stopped even trying !!!
I Amy! I am from SD also. I have been diagnosed for about 6 months. In reading about this disease, it hits , mostly women between 40 and 50 years old. I am in my middle 70s. I have been given the following medications: GABAPENTIN. 300 MG CAPS. I take one in the morning, one at noon, and two at night. In addition, DULOXETINE. HCL 30 mg. One by mouth twice a day. In addition, BUPROPION, HCL 150 MG tablet, twice a day. This has really worked for me for pain. I still get extremely fatigued periodically. I live in Arlington, SD. We have a PA here, who is quite young, but seems to investigate the problem. I have since gone back to my primary Doc because of other problems. Good luck!
I compete understand. Same here. Sorry I don’t have encouragement but, I understand and am with you here in Southern Indiana.
I try not to get excited about drugs that are preliminary. Most don’t make it to market.
I will say though that I am having a lot of success with low-dose naltrexone. Now if only the medical system would catch up. I feel like I am educating the medical/pharmaceutical industry in the Central Valley of California!
@Marsha Vomastic: Same here. LDN has proven effective with my all-over pain management however, stiffness and pain from being active (exercising, gardening, painting, leisure walking, etc.) has no management solution. Except staying perfectly still – *chuckling*
Does this really work for you? Did your Doctor prescribe or pain management Dr. Does it help with fatigue also? I am experiencing new ailments from this everyday I wish someone or something could help me.
Freida Rainey78@gmail.com
Have you had any side effects from the LDN? I have some in the refer but hesitate
No side effects at all! It’s wonderful!
Hi! I too had to educate my pain management dr. About ULDN (Ultra love dose Naltrexone) because I’m on opioids , ultra low dose allows me to increase the effectiveness of my opioids without going up in dosage. I found it to be extremely expensive from compounding pharmacy because insurance doesn’t cover this dosage. I turned to Facebook group for LDN and was educated in how to dissolve 50mg naltrexone (taking a quarter of it) and diluting it and using a pipette (found on amazon). But I have noticed it’s not working as well as in the beginning. Now have a trail run of Ketamine. Pharmacist says if u increase ULDN and ketamine as you lower opioids I can eventually replace opioids for that protocol. As far as any of the so called Fibro meds none worked and most made me gain weight. Hopeful that one day there will be a successful medication or better yet, a cure.
Can anyone provide advice on decreasing opiods (to what level) before you introduce LDN?
I did the Famvir and Celebrex combination about four years ago but I didn’t do anything for me.😏
https://www.sciencedirect.com/science/article/abs/pii/S0306987719303263
Gadolinum is contributing to the epidemic. Please post!!
Gadolinum? I’ve read the article but don’t understand to be honest, Is there a way to reduce it?