Major Trial for Fibromyalgia Drug Targets Sleep Problems

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Sleep-drugs-moderate-effects.jpg


Tonix believes a sublingual form of cyclobenzaprine will be the first drug to reduce the problem of non-restorative sleep in Fibromyalgia. Non-restorative sleep is also the main sleep issue in ME/CFS (chronic fatigue syndrome)
Dr. Daniel Clauw, fibromyalgia expert believes the new drug might work: "The efficacy and tolerability profile of TNX-102 SL as demonstrated in prior clinical evaluations supports this candidate as a promising treatment for fibromyalgia.”

Cyclobenzaprine (brand names Amrix, Flexeril and Fexmid) s a muscle relaxer medication used to relieve skeletal muscle spasms and associated pain in acute musculoskeletal conditions, that is also used off-label for fibromyalgia treatment. It has been shown to be effective in FM but has no proven benefit in reducing muscle spasms after about two weeks.

An earlier fibromyalgia trial found that very low dose cyclobenzaprine significantly improved pain, tenderness, and depression over eight weeks - indicating that very low doses of the drug can be effective for longer than two weeks when treating sleep in FM. An EEG indicated that significantly more people taking CBP group had increased nights of restorative sleep. The increase in nights with more restorative sleep was correlated to improvements in fatigue and reductions in depression.

Muscle spasms and tightness can often increase during sleep but the mechanism by which the drug is working is not clear. The authors of the study suggested, however, that the drug may be affecting serotonin levels (and reducing glutamate expression) and sympathetic nervous system functioning. Genetic linkages have associated FM with genes encoding receptors for these areas. Increased sympathetic nervous system functioning has been associated with poor sleep in ME/CFS. This earlier study clearly provided the genesis for this larger trial of sublingual cyclobenzaprine in FM.

Tonix CEO Dr. Seth Lederman stated “We are proud to be developing a new prescription medicine for people suffering from a condition that, despite its prevalence, remains inadequately addressed,” . “If approved, we believe TNX-102 SL would offer a clinical profile that would be highly differentiated from currently-marketed drug products, and would be the first medicine for fibromyalgia to target non-restorative sleep.”

The company seems confident and is opening a huge trial in 35 sites. If you are interested in participating =contact Mark R. Schmal via e-mail mark.schmal@premier-research.com or + 1 512 852 6912. For a list of the 35 study locations recruiting participants please follow the link.
 
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Who Me?

Well-Known Member
First how is this different then oral flexeril and 2nd this is not on my insurances formulary. I had to call around to find a cheap place to get it.

Also drugs the hell out of me. I could never take it for sleep because of that.
 

Whistle Blower

New Member
Flexoril was a wonder drug in the beginning and then I became emotionally unstable on it. It was once marketed as an antidepressant and then they realized that it was better served as a muscle relaxer. It made me so emotional, I felt nuts. Nothing new about this...just a different way of giving.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Flexoril was a wonder drug in the beginning and then I became emotionally unstable on it. It was once marketed as an antidepressant and then they realized that it was better served as a muscle relaxer. It made me so emotional, I felt nuts. Nothing new about this...just a different way of giving.
The difference might be in the dose: this is ultra low dose - do you think you took it in a lower dose?
 

Angie

Member
Drugs and their side effects scare me. I often find that I'm better off suffering as I normally do than with the side effects. I take as few as I can get away with. I got tired of not being able to sleep well and stay asleep so I bit the financial bullet and went to see a naturopath I saw years ago while I was still working and could afford it better. She put me on Pulsatilla. That first night I slept better than I had in years. Now a few months in on it and I'm sleeping 8+ hours a night, I fall back to sleep if I wake and feel like I'm getting good restorative sleep. The improving bags under my eyes reflect this. I still have 7 years of sleep deprivation to make up for and I am no where near cured, I function at 2/10, but at least with this improved sleep it's less of a struggle to do self care, eat, and get through the day.
 

Issie

Well-Known Member
My best meds for POTS and FMS are Bentyl (mild muscle relaxer) and Tramadol (works on pain and neurotransmitters and used off label for cases of non response of other meds for depression). Taken at night gets me out of pain enough to sleep and doesn't cause depression like other pain meds do. Calms my over sympathetic nervous system down.

Issie
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Drugs and their side effects scare me. I often find that I'm better off suffering as I normally do than with the side effects. I take as few as I can get away with. I got tired of not being able to sleep well and stay asleep so I bit the financial bullet and went to see a naturopath I saw years ago while I was still working and could afford it better. She put me on Pulsatilla. That first night I slept better than I had in years. Now a few months in on it and I'm sleeping 8+ hours a night, I fall back to sleep if I wake and feel like I'm getting good restorative sleep. The improving bags under my eyes reflect this. I still have 7 years of sleep deprivation to make up for and I am no where near cured, I function at 2/10, but at least with this improved sleep it's less of a struggle to do self care, eat, and get through the day.
I have never heard of Pulsatilla - what is it?
 

Issie

Well-Known Member
I have never heard of Pulsatilla - what is it?
It's a homeopathic med. with homeopathy it is based on the persons constitution and symptoms. It is a little bit like giving a dose of what would cause the symptoms to counteract the symptoms. There is a lot to consider to get the right choice at the correct dose for each person. That being said, if you get the wrong one its not likely to hurt you - it won't help either. There is a correct way to take it and a wrong way. Read up on it. It's fascinating and over the years I've found it to be helpful if you get the correct remedy.

Issie
 

tatt

Well-Known Member
magnesium is a muscle relaxant and many peope with ME have been shown to have low magnesium levels. I'd like to see any new drug tested against magnesium to ee if it works better. Magnesium has few side effects (see below) in normal use.

Some forms of magnesium supplement (especially the cheapest magnesium oxide) are laxative. Magnesium maleate is possibly the best form for those with ME - or put epsom salts in a warm bath as magnesium can be absorbed through the skin. It will dry your skin a bit.

Doses less than 350 mg per day are safe for most adults. Large doses might cause too much magnesium to build up in the body, causing serious side effects including an irregular heartbeat, low blood pressure, confusion, slowed breathing, coma, and death.

I take some at night when I remember (with calcium) and my sometimes irregular heartbeat is no longer irregular while my usually low blood pressure is nearer average.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
magnesium is a muscle relaxant and many peope with ME have been shown to have low magnesium levels. I'd like to see any new drug tested against magnesium to ee if it works better. Magnesium has few side effects (see below) in normal use.

Some forms of magnesium supplement (especially the cheapest magnesium oxide) are laxative. Magnesium maleate is possibly the best form for those with ME - or put epsom salts in a warm bath as magnesium can be absorbed through the skin. It will dry your skin a bit.

Doses less than 350 mg per day are safe for most adults. Large doses might cause too much magnesium to build up in the body, causing serious side effects including an irregular heartbeat, low blood pressure, confusion, slowed breathing, coma, and death.

I take some at night when I remember (with calcium) and my sometimes irregular heartbeat is no longer irregular while my usually low blood pressure is nearer average.
What about magnesium threonate - have you tried that? I haven't taken magnesium in decades but I just ordered some...
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
This medication is the only one that helped me rest/sleep.
It just shows sleep problems can be tackled in such different ways...This is the most interesting "sleep drug" that I've seen.
 

tatt

Well-Known Member
What about magnesium threonate - have you tried that? I haven't taken magnesium in decades but I just ordered some...
Dont think I've tried that one. I've experimented with various types though. Thank you for reminding me that I need t take some more, tend to take it only when feeling ill and I should be doing so more regularly.
 

Paw

Well-Known Member
I'm going to try it. Especially since it might help with TMJ -- and I'll bet my sleep issues are largely because of my autonomic neuropathy, which the cyclobenzaprine is supposed to calm. If it helps my RLS and aching joints, all the better.

I'll need to monitor its interaction with Cymbalta and 5-HTP (I've had an episode of serotonin syndrome -- no fun.)

But does anyone know what constitutes a "low dose"? Looks like the smallest tabs Humana covers is 5 mg.
 

John Willton

New Member
Carisoprodol is a perfect solution of the pain. It is used to inhibit the pain sensation from the site of injury to the brain. It also works by inhibiting the reuptake of serotonin and norepinephrine neurotransmitters in the brain. It focuses Central nervous system and block pain sensation in between the nerves at the site of injury to the brain.

Carisoprodol come with the brand name Soma, Pain O Soma, Prosoma etc. You can easily get Carisoprodol from our online pharmacy ALLCHEMISTSTORE at a reasonable price and can save your valuable time and money.
 

shira

Member
i took flexeril in the early days of my cfids a long time ago. it had dreadful side effects and got me quite depressed-it helped muscle pain, but that was it-i could never recommend it.
 

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