Three New Fibromyalgia Drugs Could Be On The Way

Three New Fibromyalgia Drugs Could Be On The Way

By Donna Gregory Burch

donnasnowday

Donna Gregory Burch

During the year following my fibromyalgia diagnosis, my rheumatologist prescribed five different drugs in an attempt to relieve my pain.

None of them worked.

The current fibromyalgia drugs on the market are notoriously ineffective. I remember my rheumatologist sharing a surprising statistic that I’ve since verified through my own research: The most effective fibromyalgia drugs provide at least a 50 percent reduction in pain in only about one-third of patients.

We desperately need better treatments, and drug companies are anxious to deliver them. Two new fibromyalgia drugs are currently in clinical trials, and a third one will be tested next year.

Two of these prospective treatments are cousins to drugs already on the market, and one takes a completely unique approach to fibromyalgia. I’ll start with that one first.

IMC-1: A blockbuster combo?

The U.S. Food and Drug Administration (FDA) has fast tracked IMC-1, a combination of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, for a Phase III trial next year.

Dr. William “Skip” Pridgen, the combo’s discoverer, believes the HSV1 virus, commonly associated with cold sores, may be a culprit in fibromyalgia. He developed this theory while treating the gastrointestinal issues of fibromyalgia patients in his growing surgical practice in Tuscaloosa, Alabama.

Pridgen noticed patients’ symptoms seemed to wax and wane over time and speculated these flares may be caused by the activation of an undetected virus. He tested his theory by prescribing common antiviral medications and noticed some slight improvement among patients.

Around the same time, he began giving fibromyalgia patients samples of Celebrex, hoping the anti-inflammatory would reduce their overall pain. The patients who took both the antiviral and the Celebrex began reporting substantial improvements in their fibromyalgia symptoms.

In 2014, Pridgen and his research team conducted a phase II study involving 143 fibromyalgia patients at 12 U.S. clinics. Patients either received IMC-1 or a placebo. After 16 weeks, 37.9 percent of patients reported a 50 percent or greater reduction in pain. That’s slightly better than Cymbalta, the most effective of the three FDA-approved fibromyalgia drugs. Side effects were low, with more patients from the placebo group dropping out of the trial due to adverse reactions than those taking IMC-1.

“We had pain reduction levels that rivaled or were comparable to other fibromyalgia drugs,” Pridgen said. “It wasn’t just that we reduced their pain. In all the measures we looked at [including fatigue, anxiety, headaches, TMJ, etc.], we seem to have an impact overall.”

“We’re radically different [from other fibromyalgia drugs],” Pridgen continued. “Instead of just trying to reduce pain perception, we think we’ve discovered what is at the root cause [of fibromyalgia].”

Pridgen expects even better results from next year’s phase III trial because it will use the dosage he’s been perfecting in his practice for the past six years. Phase II used a lower, less effective dose, he said.

Phase III may enroll up to 1,200 patients at around 60 sites, some of which could be international. Several major pharmaceutical companies have already expressed interest in IMC-1, and a new drug could be on the market within three years.

Mirogabalin: A better Lyrica?

Millions of patients were thrilled when Lyrica became the first FDA-approved drug for fibromyalgia in 2007. But for many, Lyrica’s real-life performance didn’t live up to drugmaker Pfizer’s picture-perfect TV commercials.

Based on Pfizer’s research, only around 1 in 5 fibromyalgia patients experience at least a 50 percent or greater reduction in pain. And worst still, Lyrica is well known among those in the fibromyalgia community for its troubling side effects.

I know a few people whose lives have been changed by Lyrica, and I’m grateful for any treatment that helps – even if it only helps a small percentage of us. But at the end of the day, for most of us with fibromyalgia, Lyrica hasn’t lived up to the hype.

Japanese drugmaker Daiichi Sankyo is now testing what could be Lyrica 2.0.

Lyrica and Daiichi’s new drug, mirogabalin (aka DS-5565), both relieve pain by binding to the body’s calcium channels. For readers who love more technical explanations, Alyssa Dargento, Daiichi’s public relations director, explained how Lyrica and mirogabalin differ: “Like Lyrica, mirogabalin preferentially and selectively binds to the a2δ subunit of voltage gated calcium channel proteins, which may help to regulate how the brain processes pain signals. However, in vitro studies have shown that mirogabalin has a unique binding profile and long duration of action at voltage gated calcium channels.”

In simple terms, Daiichi believes mirogabalin works better and with fewer side effects than Lyrica, and it’s investing millions in clinical trials to prove it. In fact, part of Daiichi’s research effort will involve pitting Lyrica and mirogabalin head-to-head against one another in trials.

“The clinical efficacy of mirogabalin was studied in two phase II, multicenter, randomized, double blind, placebo and active comparator-controlled adaptive studies in patients with diabetic peripheral neuropathic pain (DPNP),” Dargento said. “These data provided proof-of-concept for mirogabalin as a potential treatment for DPNP and suggested that mirogabalin may have utility in other chronic pain conditions, including fibromyalgia.”

Daiichi’s global ALDAY research program includes three phase III studies, which will compare various doses of mirogabalin, Lyrica and placebo in fibromyalgia patients with the main goal of relieving pain. There also will be an open label safety study. (ClinicalTrials.gov includes information on these trials.)

These are huge studies involving some 4,000 fibromyalgia patients at around 800 clinical centers worldwide. Daiichi is still recruiting patients for at least one of its studies.

“The top line results for the ALDAY phase III clinical trials are anticipated in calendar year 2017,” Dargento said. “We plan to share the results from the clinical trial program in publications and at medical meetings in the future.”

(As a footnote to this section, I read last year that Pfizer is working on a time-released version. I reached out to Pfizer at least twice in an attempt to interview someone for this story, but no one responded to my requests.)

Tonmya: Better sleep = less pain?

Cyclobenzaprine (Flexeril) was the final drug my rheumatologist prescribed for me before we essentially gave up on pharmaceutical treatments for fibromyalgia. I still have an old bottle of it that I reach for at bedtime when I’ve had a particularly awful day. It doesn’t stop the pain; it just knocks me out so I don’t feel it.

Unfortunately, cyclobenzaprine’s sedating effect works so well that I can barely function the day after taking it. I rarely use it because it makes me groggy through midafternoon.

But I may revisit cyclobenzaprine when and if Tonix Pharmaceuticals Holding Corp. releases Tonmya (aka TNX-102 SL), a new sublingual formulation of cyclobenzaprine HCL 2.8 mg.

Some fibromyalgia specialists believe, at its heart, fibromyalgia is really a sleep disorder, and I’m sure there are more than a few patients who would agree. Restorative sleep can be hard to come by for those of us with fibromyalgia.

The purpose of Tonmya is to improve the sleep of fibromyalgia sufferers.

“We think that sleep improvements lead to improvements in pain,” said Dr. Seth Lederman, Tonix’s CEO. “Sleep is not just a symptom. Sleep quality is part of the problem. If you can improve the sleep quality, then you can improve the other symptoms.”

Tonix just recently finished enrollment for its phase III AFFIRM trial of Tonmya, which involves 500 fibromyalgia patients at 35 U.S. clinical sites. AFFIRM’s main goal is to relieve fibromyalgia pain by at least 30 percent.

Trial results are expected by the end of September. If all goes well, Tonmya could be available for patients in 2018.

Since Tonmya contains a lowered dose of cyclobenzaprine, daytime grogginess shouldn’t be an issue for most users. In a previous trial, more people experienced daytime sleepiness using placebo than Tonmya.

The drug’s sublingual form also means absorption is much faster than its predecessor – just three minutes for Tonmya versus 45 minutes for cyclobenzaprine. (Those of us who use cyclobenzaprine to escape from pain know all too well how brutal those 45 minutes of waiting can be.)

In the earlier trial, temporary numbness in the mouth was the most common side effect. About 50 percent of patients reported oral numbness, which disappeared within 30-45 minutes of using Tonmya.

“We don’t have an impression that it’s a side effect that would limit its use,” Lederman said.

Tonmya also is being studied in those with post-traumatic stress disorder.

TD-9855 – On hold

In 2014, Theravance, Inc. announced positive results from a phase II study of TD-9855, a norepinephrine and serotonin reuptake inhibitor, in patients with fibromyalgia. Not only did it relieve pain better than placebo, but it also improved fatigue – a quality that’s unique among the fibromyalgia drugs currently on the market.

Unfortunately, TD-9855’s use as a potential fibro treatment has been put on hold.

“Theravance Biopharma has shifted the development strategy for the program and has opted to focus on a different therapeutic target (neurogenic orthostatic hypotension),” said Tim Brons, executive vice president of Vida Strategic Partners, the firm that’s handling Theravance’s public relations effort. “The company believes this is a more viable commercial opportunity for the drug and is planning to conduct a phase II study.”

Now it’s your turn: Which of these new fibromyalgia drugs sounds the most promising? If they all make it to market, which – if any – would you be most interested to try? Tell us in the comments section!

Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She covers news, treatments, research and practical tips for living better with fibromyalgia on her blog, FedUpwithFatigue.com. 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 24 comments for this article
  1. Nichol at 5:20 pm

    Barbara Chlumsky – I’m currently taking Savella (50 mg twice a day). I didn’t experience the severe nausea stomach upset that a lot of people have trouble with at first but it doesn’t help me nearly as much as Lyrica did (i had to stop the Lyrica because i not only gained 24 pounds in the first 6 weeks but my diastolic blood pressure rose 35 points and my systolic blood pressure rose 23 points, my hands, legs, and feet became very swollen, and the additional blood pressure medication (Bisoprolol 5mg twice daily) and water pill HCTZ (Hydrochlorothiazide 12.5 mg for the excessive swelling) did not reverse the side effects at all unfortunately.

    The Savella doesn’t help my nerve, muscle, bone, aka whole body pain BUT….. I also suffer from SAD (Seasonal Affective Disorder) and it was the best it’s been in over ten years this past winter and I really think the Savella is what helped it. However, now I’m experiencing increased swelling and dangerously high blood pressure. My Rheumatologist thinks it’s the Savella so he wants me to go off of it slowly but I’m terrified!

    Has anyone suffered from what was called “growing pains”? I was originally diagnosed with them in the late 70’s/early 80’s when I was a kid shortly after getting chicken pox? Several years later i was diagnosed with Juvenile Rheumatoid Arthritis but not until my symptoms flared up again shortly after being diagnosed with Mono at 13.

    Most doctor’s think I’m crazy or it’s all in my head but I know more is going on than just Fibromyalgia. I have positive ANA and RA factors but my Rheumatologist says it’s from the JRA and is a false positive but I’ve also read it never goes away either so who knows. I also would never had even had a Fibromyalgia diagnosis if i just left my concerns and complaints fall upon the deaf ears of my Primary Care Doctor and other specialists. I finally took my life into my own hands and looked up Rheumatologists and made an appointment which has helped a bit but I still feel there’s more to this and I’d even question myself about being a hypochondriac or worse but I haven’t been wrong yet when it comes to my health so why stop now? I’m still trying to find a new Rheumatologist or to get a second or third opinion as when i was sitting in my Rheumatologist’s office last week with a butterfly rash across my face with another lighter rash on my chest, hands, and arms, with hands so purple and swollen worse than I’ve ever experienced before to the point that I couldn’t close my hands or pick up my phone, my legs and feet were so swollen the pressure broke the top of my patent leather dansko shoe I was wearing on my left foot, and when I asked my doctor what i could do for the increased swelling he said nothing that he was already giving me Ibuprofen for the swelling and there was nothing more he could do. I guess it’s a fairly better answer than I received the week prior after seeing a covering physician at my Primary Care Doctors office that told me to come in asap or call an ambulance if i cant drive as I also have a blood clotting disorder & they thought I might have a clot but the covering doctor told me she wasn’t going to order a doppler ultrasound of my arms & legs – basically my whole body & instead said to lose weight (lost 14 pounds in the past 8 days before seeing her), she said to lower my salt/sodium intake (did you review my labs? I have low sodium levels actually and don’t use salt), she then said to stay away from processed foods and only shop around the perimeter of the grocery store (check and double check – my son has severe food allergies so there’s no processed food in our house, only fresh fruit and veggies and lean protein. ..I even cook an organic nitrate/sodium free turkey breast for lunches because my son can’t eat deli meat lady), & lastly exercise (I’m trying to walk once or twice daily at the park across from our house but my feet and legs swell even worse after standing or walking for more than a few minutes causing more pain and quite frankly I’m in enough pain as it is thanks.

    It’s hard not to get frustrated but we have to take charge of our own lives, never giving up, and listening/believing our own instincts; especially when they’ve never been wrong…..yet ;0)

  2. Laurence badgley at 8:12 am

    It is notable that the benefits reported for these “new” drugs do not exceed the placebo effect, i.e., the power of the healing mind. As more and more sufferers discover the natural benefits of Cannabis all these synthetics will fall to the wayside.

  3. Hutton at 4:04 pm

    I’ve been fortunate that I found Dr. Pridgen and received his formula for over 4 years now. I too was at my limits with pain, thinking that I was not far from death and relief of the permanent kind. The first month on the protocol was rough as I was warned, flu-like symptoms, flair-up and even thoughts of suicide. Dr. Pridgen checked on me regularly and encouraged me to push through and I did. After that first month I can tell you I’ve had no side effects and I would estimate 75-80% reduction in fibro pain (I have degenerative disc disease from scoliosis so pain free isn’t possible). You all know the type of pain I’m talking about the deep joint in every part of your body pain! I too have tried every pharma option for fibro and couldn’t tolerate side effects or found no real benefit so I was skeptical too. Please if you’ve found alternative solutions that work, God Bless you and stay with what works but if your like me looking at a dead end not knowing where to turn next please have hope. I think the anti viral approach is the right path and this protocol hits at the cycle of cell regrowth as well as addressing symptoms. I’ve helped several friends and family get to Dr Pridgen and all but 1 have seen significant improvement! One friend who’s had CFS said that this treatment has given her her life back and believe me this friend is full of life! I think this approach is not only better than the rest but it will also lead to further research and possibly a cure. I’m a believer and live with relief and hope. I pray for the same for everyone that suffers from fibromialigia or any of the functional syomatic syndromes.

  4. Wm "Skip" Pridgen MD at 7:55 pm

    First of all an allergy to sulfa does not preclude using Celebrex (actually sulfonamide is what needs to be avoided-this is different) I have had hundreds who took Celebrex who had sulfa allergies.
    Secondly, the Celebrex must be given along with the famciclovir for the meds to work, individually not much happens.
    Don’t forget Jarred Younger PhD at UAB seems to be making headway with Low Dose Naltrexone.

  5. Brenda. at 10:19 pm

    I also have been in Acyclovir for years. And tried Celebrex in its hay day. No help, not even a little. On top of all these fibro and mecfs problems I also have shingles ,often, since 1970. So none of this will help me either. Hormones. Hormone pellets helped me more than anything. For 6 years I was getting hormone pellets inserted in my hip. I know all the warnings and risk, but I have had this pain and fatigue for 3/4 ths. Of my life, so I thought that made as much sense as anything. And it helped. A lot. But now insurance no longer pays for them so I am in a world of hurt again. If I ever become rich, and at this point it’s pretty impossible, I will get them again.

  6. Barbara Chlumsky at 2:39 pm

    Years ago I used Savella with some success. It was too expensive, so I quit. Have any of you had any luck with it. It may be close to being generic.

    Thanks.

  7. Sandra Clark at 11:11 am

    Would use none…..every pharmaceutical I tried either triggered high anxiety or deep depression and thoughts of sucicide…..I use essential oils, magnesium Calm, pure supplements with no additives, hot packs, cold packs, Mag A Hol …..during “flare times”. I just try to be as comfortable as possible and be good to myself.

  8. Kathy Smuk at 10:04 am

    I am allwegic to sulfa so anything with Cymbalta would be impossible for me to take. But that one sounds the best.

  9. Jeni Davies at 2:17 am

    Anything with the word “gabalin” I would avoid.. As my experience with pregabalin was not a pleasant one! Esp.the detox!! Horrendous! I like the idea of an antiviral mixed with an anti inflammatory as I live with RA as well as Fibromyalgia. Although saying that and I’m sure many would agree? that the money being spent on drug research would far better be used researching the cause and therefore the cure.

  10. SUSAN at 7:06 pm

    I have used Famvir for years for cold sore outbreaks, usually after surgeries…but it has not worked for pain or fibro symptoms. Celebrex didn’t touch pain…I used this prior to official fibro diagnosis and it did nothing. It also does have heart warnings. If I remember correctly they actually changed the formulation of Celebrex after it was pulled from the market for a while due to heart issues.

  11. Ellen Rhoades at 5:30 pm

    I am to the point on giving up on big pharma. I think they like making drugs with side effects so they can make other drugs to counter the side effects … going to go a with a whole new approach and see what happens.

  12. Sheryl Donnell at 3:05 pm

    None of these are particularly exciting for me. They are all just reboots of other drugs and none of them have really great overall outcomes. I was hoping for something entirely new. I could take meds for sleep now (cheaper), Lyrica is dangerous so a newer version is not likely to be any safer , Celebrex also has a lot of heart risks associated with taking it so I don’t like it any better. How about something new?

  13. Catherine Erwin at 9:51 am

    I an interested in the anti-viral medication. It seems that I have mild flu-like symptoms with flare-ups — not cold symptoms — but achy neck, shoulders, arms, and legs. I remember saying to a doctor: Why do I always feel like I have the flu? No answer, of course, just ”
    the look”.

  14. Nancy R at 9:18 am

    I would like to try the viral combination. I am allergic to Sulfa and that might be a problem.
    The flexoril sublingual sounds promising.
    The Lyrica 2 sounds like more of the same….too risky.

  15. Elly Rhoades at 9:14 am

    Lyrica caused severe dizziness, Gabapentin causes me headaches, vertigo, and a creepy crawling feeling between my scalp and skull. Deptran and Sinequan also known as Doxepin depleted my melanin. Tylenol has induced auto-immune hepatitis. Fibromyalgia has triggered tinnitus. Along with the other conditions associated with Fibromyalgia (IBS which has since been diagnosed as Diverticulosus), CFS and probably has triggered other things wrong with me, I am tired of drugs. I figure that a lot of things that are wrong with us, along with the increase in other diseases, has been brought about by the environment and the damage we are doing to the earth.
    I would like to see more research done on the cause and less experimenting with drugs to ease our pain. Too often the side effects are harder on us than Fibromyalgia is.

  16. Krissy at 9:13 am

    I wouldn’t take either drug or any new drug. I am weaning off Neurontin now, which was given to me for RLS many years ago before it was used for pain. I don’t feel it did me any good except for the help with RLS. But opioids will kill RLS too, and since I am on such a high MQ now, I feel I can get off Neurontin and be one drug down. None of my doctors ever asked me to try Lyrica or Cymbalta and I never did. I’d like to get into the heads of some doctors about this right now and find out how they really feel. Mine did not go for the new medications and I’m glad. I also don’t care to try a drug that is not a proven treatment for a disease that is still in research.

  17. Janet Komanchuk at 8:54 am

    Donna, Thank you for your research for “Three New Fibromyalgia Drugs…”

    As a survivor of long term painful, chronic, debilitating fibromyalgia who has been in remission, both pain and prescription free, for more than 15 years I follow the research and comments closely. I too tried everything I could find: medicine cabinets full of prescriptions (mostly ineffective with side effects of their own to contend with), countless alternatives from tapping to self hypnosis, acupuncture, physio therapy, body talk, nutritionists and anything else I could find. Still I continued to get worse. I was my physician’s worst nightmare of a patient, for nothing we tried helped.

    Even though he did not succeed in providing long term help for my fibro, Dr. V. did help me by continuing to research and offer the latest prescriptions that might help and referrals to numerous specialists that could have the answers we both sought. Never did he tell me it, as others before him had, that it was all in my head. He never gave up on me, and I never gave up on myself. Even as I was barely able to move, unable to look after my home or myself, I sought help from yet another source. I learned of Joy of Healing, a unique mind/body/spirit wellness work from my uncle. “Are you willing to try this?” he asked. Scared to death, fearful of the nursing home I could see in my near future, I embraced this new healing modality.

    For me Joy of Healing was the answer. Together we worked to identify and resolve the numerous unresolved issues in my life that, no matter how hard I tried to ignore them, kept resurfacing and making me so very ill. They encouraged me to adopt a healthy lifestyle designed specifically for my needs. Eliminating wheat, dairy, sugar and most processed foods, juicing vegetables that provided the nutrients my body lacked, walking-slowly at first, water exercises with less impact on my inflamed and aching joints… were all part of my journey to wellness. Thanks to Joy of Healing and my own efforts, that at last had direction and focus, I have my life back, renewed and full.

    Never give up hope. Research, as Donna has. Consider alternative and complementary approaches to wellness along with the medical. Trust your intuition to guide you. Keep hope alive and never give up!

  18. Lisa at 8:36 am

    I would not even try TD-9855. SNRI’s have caused terrible reactions for me and were additionally difficult to stop taking.
    Tonmya sounds like something that might be handy to have on hand when I have really overdone it. I take a different muscle relaxer (Baclofen) that does not make me foggy-brained, so unless it lost its effectiveness for some reason, I would not have reason to try something new.
    IMC-1 sounds the most promising to me, though I am not without serious reservations. I too believe there is a virus behind Fibromyalgia. After experiencing shingles, I have observed in my own body that fibro flares behave very similarly. I would not take it until it had been on the market for a while though, if ever, as I have little confidence in the process and oversight of the introduction of new drugs in the marketplace.
    I don’t believe there will be any pill on the market any time soon that will truly help me. I benefit greatly from therapeutic massage (expensive and not recognized/covered by insurance), lots of gentle stretching throughout my day, enough-but-not-too-much exercise/activity,good nutrition, and stress management.
    I say “no” to pretty much everybody and everything that is not work-related or joy-giving. Even at work, I do my best to avoid toxic situations, and when they are inescapable I mentally tune out as much as I can. I see a therapist and am always fine-tuning my attitude, because my attitude is my best weapon against the beast.

  19. Lyn at 8:27 am

    Low dose naltrexone. It’s safe, cheap and has given me my life back. An orphan drug, the drug companies can’t make $$$$ off it so no one is talking about it. Do the research yourself, inform your doctor who has probably never heard of it. You won’t regret it.

  20. Yeshua at 7:59 am

    Lies. Medical cannabis is the answer. Don’t trust the pharmaceutical companies, they only work for money/greed.

  21. Alyce Clarke at 7:33 am

    I had shingles in 2003, almost died. Found Lyrica for the PHN, I do have the weight gain, but the Lyrica does help. Pain never goes away, it just numbs the area for awhile. Still suffering and I’ve tried it all, nerve block, etc. Another life with pain.

  22. Kristine at 5:38 am

    Well writen, thank you for the information.
    I think over the last 15 years, I’ve tried close to 35 different medications ( it very well be more than 35). It’s more than frustrating to walk into the pain specialist or rheumatologist office and report another pain medication didn’t work.
    In fact the same old story gets old.
    I don’t get my hopes up any more and I hesitate to try new medications knowing that a new medication brings a new set of side effects to cope with.
    I guess I can’t honestly choose between the new ones listed above. I’m pretty sure someday I will have the opportunity to try them as my pain specialist sees fit. It pretty much depends on ingredients because I get terrible reactions to most and end up stopping them.
    I hope with all my heart a cure, or at least help is found.
    Gentle hugs to all pain warriors who get up to fight everyday.

  23. Bri at 5:34 am

    As far as I’m concerned, I’ve already found the perfect treatment for fibromyalgia: cannabis, especially ultra low-THC, high-CBD strains that are virtually non-psychoactive. I’m not interested in anything else big pharma has to offer because everything they come up with has side effects, like the massive weight gain that comes with Lyrica. No doubt, any drug based on it or made from it will cause the same problem.

  24. Jackie T. at 3:52 am

    Regarding which new medicine sounds promising, I’m not sure about any of them.

    I can’t take anything with sulfa because I’m allergic so anything with Celebrex is out.

    A better Lyrica, I don’t know about that one either. Lyrica is related to gabapentin. I used to take Gabapentin and it scrambled my brains. Didn’t really relieve pain and just made me mentally foggy and couldn’t think straight.

    I think the more scientists discover about what causes fibro pain, more medicines will be developed that work.

    I just wish something would deaden this pain.