A non-addictive, non-opioid analgesic is on track to become the first newly approved pharmaceutical treatment for fibromyalgia in more than a decade.
Last month, Tonix Pharmaceuticals Holding Corp. announced TNX-102 SL, a sublingual version of the common muscle relaxer cyclobenzaprine (brand name: Flexeril), met its primary goal of relieving pain during a randomized, double-blind, placebo-controlled trial.
The 14-week RELIEF trial enrolled around 500 participants at 39 sites across the country. During the first two weeks of RELIEF, participants received 2.8 mg of TNX-102 SL or a placebo pill. For the remaining 12 weeks of the trial, participants received either 5.6 mg of TNX-102 SL or placebo.
Nearly 47% of participants who received the 5.6 mg dose reported a 30% or greater reduction in pain.
“TNX-102 SL at 5.6 mg showed statistically significant and clinically meaningful improvement on the primary endpoint of reducing daily pain as well as showed activity in key secondary endpoints of improving sleep and reducing fatigue,” said Dr. Seth Lederman, president and CEO of Tonix Pharmaceuticals. “One of the biggest challenges in drug development is finding a dose that balances efficacy and tolerability. We are pleased with the consistent effects of TNX-102 SL 5.6 mg on the primary endpoint of daily pain as well as the tolerability of this dose in the RELIEF study.”
The most commonly reported side effects included tongue/mouth numbness and tingling, tongue/mouth pain/discomfort and taste impairment. These side effects were temporary and generally disappeared within an hour of taking TNX-102 SL.
Tonix is currently recruiting for a second 14-week trial called RALLY, which will follow the same timeline and dosing as the RELIEF study.
Fibromyalgia patients who are interested in participating in the trial should visit RallyStudy.com for more information.
In 2016, it appeared TNX-102 SL wouldn’t come to market as a fibromyalgia treatment after the drug failed to meet the threshold for pain relief when given at a lower dose of 2.8 mg. But instead of giving up entirely on the potential of TNX-102 SL, Tonix launched two new phase 3 trials last year using 5.6 mg in hopes the higher dose would have greater pain-fighting ability.
While many pharmaceutical companies halted their clinical trials due to the COVID-19 pandemic, Tonix continued the RELIEF trial through last spring and into the early fall.
As RELIEF was winding down, Tonix began recruiting fibromyalgia patients for the RALLY trial. The company is hopeful that completing the identical studies back-to-back will help the company satisfy U.S. Food and Drug Administration (FDA) requirements and bring TNX-102 SL to market as quickly as possible.
If the RELIEF and RALLY trials are both successful, Tonix plans to submit a new drug application to the FDA next year seeking approval for TNX-102 SL as a fibromyalgia treatment.
Results from RALLY are expected during the second half of 2021.
TNX-102 SL targets the disturbed sleep of fibromyalgia patients, which in turn should lead to reductions in pain, fatigue and other symptoms.
“The sleep disorder specific to fibromyalgia has been called ‘non-restorative’ sleep,” Lederman explained. “Dr. Harvey Moldofsky, professor emeritus of psychiatry and medicine at the University of Toronto, founding director of the University of Toronto Center for Sleep and Chronobiology and member of the Tonix Scientific Advisory board, first recognized the central role of non-restorative sleep in the pathogenesis of fibromyalgia.
“Our program is based on the subsequent pioneering work of Dr. Iredell W. Iglehart III, assistant professor of medicine, part-time, division of rheumatology, Johns Hopkins School of Medicine and member of the Tonix Scientific Advisory Board, who recognized that a sleep-focused cyclobenzaprine treatment protocol had the potential to target non-restorative sleep and lead to improvement of fibromyalgia at the syndromal level,” Lederman continued.
It’s been more than a decade since the FDA has approved a new treatment for fibromyalgia, and patients are desperately in need of new solutions to manage chronic pain.
“TNX-102 SL has the potential to be a new non-addictive, non-opiate analgesic for the management of fibromyalgia which is particularly important given that fibromyalgia is a chronic pain condition,” said Dr. Gregory Sullivan, chief medical officer of Tonix. “Approximately one-third of fibromyalgia patients resort to opiates out of desperation and because of dissatisfaction with available therapies. Cyclobenzaprine, the active ingredient of TNX-102 SL, has no recognized potential for addiction. …TNX-102 SL could potentially offer fibromyalgia patients who have multiple disabling fibromyalgia symptoms a first-line monotherapy with broad symptom relief and the compliance advantage of being administered once a day [at bedtime].”
Now it’s your turn: If TNX-102 SL is approved by the FDA as a fibromyalgia treatment, are you interested in trying it? Share in the comments below!
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.
I take both Flexiril and Cymbalta. They help control pain and other symptoms better than anything else I’ve tried. I’ll be first in line to try RELIEF or RALLY! Sleeping better and not needing all the naps would be a big change for the better.
I wish I could join the testing! Nothing near me! Boo hoo 🙁
I think all of us are willing to try anything.
I have taken oral Flexeril in the early years after I was diagnosed with FMS back around 1987. Sometimes I felt it gave me some relief initially and I did not have the reaction, that some people do have, of being totally “zonked” when taking the drug and are fast asleep. It did not affect me like that, so wonder if the SL version would help or not. Would possibly be interested in doing the trial now! FMS does rob you of much over the years for sure and it seems to just be getting worse as I age. I was diagnosed with MS and RA, which both have the possibility of fatigue as a symptom. I was on a Fentanyl patch of 75 mcgs, which I have decreased over several months to 25 mcg/he. I am trying to get off completely. I also have to take oral Oxycodone to relieve the pain the Fentanyl does not relieve. With the opioid crisis, physicians and the pharmacologic industry have influenced the factor of getting people off opioid drugs. Unfortunately for the people who use this drug, to help them function day to day in a responsible way, are then left to try to defend their use of an opioid medication to just exist in a life where they can have some goals or be able to have some purpose in their life!
Wow that is alot to have. I’m having a hard time with CFS and fibromyalgia but having MS on top of that, my heart goes out to you. Best if luck, you sound like a strong person, keep it up…best wushes
I took flexaril many years ago when I was first diagnosed and it was much too sedating for me and did not help my pain. If there is something different about it and if it is not an anticholinergic (can’t remember), I would try it.
I would be very interested in trying this new drug for fibromyalgia. I use a fentanyl patch now along with Cymbalta. I want to get off options but nothing else has worked up to this point. I get no restorative sleep and am tired no matter how many hours I sleep.
Hi, Sherry. I’m so sorry to hear that you’re suffering with fibro pain. Have you tried Buprenorphine?! I’ve had fibro for 13 years; used Oxycodone for 10 of them with some relief (was also on Cymbalta for some of that time, as well as Flexeril and many others I can’t remember;(). TENS machine also helps, btw. For the last 3 years I’ve been on 8mg (2 mg 4 times/day) and finally have very little pain!! I can’t recommend this medication highly enough. It doesn’t have the addictive properties of other opioids or other side effects (for me, anyway). I hope you, and any other readers of this post, check out this option. It’s changed my life!!!
I am interested in trying TNX-102 SL
I hope its a huge plus in the way of relief for the fibromyalgia suffers, my daughter being one of them. I know she would try anything at this point.
The doctors wont give her opiods and nothing else helps, or combination there of. These patients
I’m sure, would try just about anything to relieve even some of their constant, daily pains.
For most other conditions, a 47% positive for >30% efficacy would be considered meh. I think many of our MD’s have already tried Flexeril and/or Zanaflex off-label for our fibromyalgia pain symptoms and found them mostly ineffective, although I will grant that either can cause enough drowsiness to help getting to sleep. Sublingual administration will bypass some first-pass metabolism and accelerate absorption, but I can approximate that route by smashing a generic pill with a little honey and a drop of ethanol then holding under my tongue.
How long would you hold it under your tongue? …. a bottle full of ethanol???
I’ve been severely debilitated from CFS/FM for 30 years. I tried using FLEXERIL off and on for over 5 years. If I took the significantly more than the normally prescribed amount it did help me sleep better. However, it didn’t have any measurable results on reducing my fibromyalgia pain or any other pain related to my CFS or FM. Additionally, I developed a TOLERANCE to the medication within several weeks which made it totally ineffective for the ability to assist me with my sleep. I am only one patient but I used FLEXERIL over a number if years with many months and sometimes a year or longer before incorporating it again into my regime of prescriptions. Personally speaking, I am not clear what difference if any regarding its efficacy will be enhanced by simply changing the pill form into a liquid version!
Philip Snowdon
Phillip, I’m so sorry to hear how you’ve been suffering all these years. Please see my reply to Sherry above (Short version – I’ve had tremendous success with Buprenorphine). Take care!
Yes, I would try new drug. I’m desperate especially re: Not sleeping at all!! Also more pain & I also have Lyme’s ( besides other things!)
Thanks for all your hard work!! I’m sorry you’ve gone thru hard times. I send you healing thoughts & heartfelt prayers for your health & staying safe!🙏🏾🙏🏾💕
Thank you so much, Robyne! I’m sending big hugs your way! 🙂
What a sweet, kind person you are, Robyne, to care so much for others when you are in so much pain yourself. Your thoughtfulness inspired me to take time to respond to several posts on this site with info on what has helped me significantly over the last few years. In 2018, I started seeing a pain doc who switched me to Buprenorphine and it’s changed my life. Not sure if this is an option for you but I know many docs are just learning about this med so wanted to pass info along to you. Take care of yourself and know I’m sending good thoughts your way!!
I would be willing to try this Rx. I’m a bit leery because of Cymbalta. I was on it for a number of years and had to withdraw while having an NG tube. I’ve never been through anything like that in my life. I really think that was as hard as anything an addicted person would go through with opioids. The difference being, I had no cravings for Cymbalta, thankfully. I don’t know if I was ever warned about the addictive effects of Cymbalta. I know there are tons of lawsuits over that medication. I would want to know more about that aspect of TNX. I don’t like taking pain pills, so this could be a great option. Thank you for keeping us informed.
Yep, the anticholinergic aspect concerns me. Don’t need dementia, too!
That was my first thought too.
YE S, YES, YES!! I would be interested in trying the TNX-102 SL. I have been dealing with extreme pain for the past 14 years and have been on morphine up to 240 mgs/day. I am currently taking around 100 mgs /day; various doses of MS and strengths. I have been robbed of my life for the past 14 yrs!! PLEASE INCLUDE ME IN YOUR STUDIES! I LIVE IN HAWAII. IS THERE A POSSIBILITY I COULD STILL PARTICIPATE
IN THE TRIAL(S)?
In closing, a very heartfelt thank you for your interest in finding a cure for this awful disorder. Thank you for all your time, persistence and clinical trials that will hopefully help me one day! God bless you and your staff real real good!
Elizabeth, I’m so sorry to hear how you’ve been suffering!! Please see my responses to other posts above (I can’t recommend Buprenorphine highly enough!). Take care and know I’m thinking of you!
Am interested in all and any information on fibromyalgia.
I highly recommend Buprenorphine for pain relief without addictive properties of other opioids). Take care!!
Absolutely yes, I hate taking opioids but have no choice as it’s the only way I can get any pain relief.
Flexeril 1/2 of the 10 mg tablet at bedtime is the only thing that’s ever given me some sort of relief so I would definitely try this.
I am desperate to find something for pain that will actually work, so yes… absolutely I would be interested.
Thank you for posting this. I finally got my Dr.to order me some flexeril. It provides me with so much relief. This drug works for me.
Patti
Yes I would definitely try the new fibromyalgia drug for pain I have tried everything but nothing seems to work 🙁🙁
Yes I Would Be Interested In A Trial Been Dealing With Fibromyaliga For Over 25 Years
Not “novel”, was first med prescribed for me for fibro in 1990, knocks everyone out. They retooled it for sublingual 30 years later now, not awe inspiring to me. Wonder how much it beat placebo. We need new meds. Also, it is probably e trembly anticholinergic, not good for seniors.