Thursday, February 4, 2016


It's been awhile.
But now, it has a name.

A year or so ago I got approached by a woman named Laura Colontrelle-Radocaj of Dian Griesel, Int'l. She asked if I'd be open speaking with Dr. Lederman who is the CEO of Tonix Pharmaceuticals. I was aware of the clinical trial of TNX102 (Tonmya) that was taking place  so I was thrilled that I had been given the opportunity.

I really believe there are subgroups of Fibromyalgia. I also think that is why Lyrica, Savella and Cymbalta (which are all FDA approved treatment for Fibromyalgia) don't work for everyone. For me, Lyrica was worse than the Fibromyalgia. I gained weight, which is death for me, and my thoughts went to a very dark place. I can't take it. There aren't a lot medications out there that are approved so something new on the horizon was good news. 

In a nutshell Tonix Pharmaceuticals is using cyclobenzaprine in new doses and formulations for treatment of Fibromyalgia and Post-Traumatic-Stress Disorder (PTSD) which are chronic central nervous system disorders. At first I wondered why Fibromyalgia and PTSD? To me, they were on opposite ends of the spectrum until Dr. Lederman gently reminded me how many cases of Fibromyalgia start with trauma. 

Mine included.

Cyclobenzaprine (Flexeril) is an FDA approved drug that treats the muscle spasms that is associated with musculoskeletal conditions. Pain managers use it quite frequently but it's difficult to take because it makes you groggy and sleepy the next day. Well, it seems that it takes two hours  to get into the bloodstream so if you take it before you go to bed it won't take effect for two hours. No wonder people are groggy in the morning! It's been prescribed off label as a sleep aid. What I didn't know is that there isn't any benefit with this drug after two to three weeks. Actually, what is said was "the evidence of effectiveness for prolonged use is not available," and everything I've read says that this drug should not be used long term.

So why is this different? 
Flexeril is still Flexeril.

The BESTFIT protocol (BEdtime, Sublingual, TNX102SL, as Fibromyalgia Intervention Therapy.) uses a very low dose cyclobenzaprine. The great part of using it sublingually is that it enters and leaves the bloodstream quickly. It's 2.8 mg of cyclobenzaprine in this formulation. Tonmya is currently being evaluated in the 500 person AFFIRM trial for fibromyalgia. Patients have to report a reduction in pain from the baseline after 12 weeks. It is also being evaluated for safety as well as the effectiveness of the drug. 

So far approximately 42% of the patients experienced some kind of tongue or sublingual numbness. More studies will need to be done to evaluate long term effectiveness. Also they need to study if it will interact with any of the medications currently approved for Fibromyalgia. 

This isn't some ripoff company trying to float and old drug into a new "big fix" for Fibromyalgia. This doctor had a thriving practice and then committed what he said was, "professional suicide" by going into research on a central nervous system problem like Fibromyalgia. In his opinion, non restorative sleep changes the central pain pathways and if part of that can be fixed then patients should see a reduction in pain. 

We really do need the sleep. I don't know about anyone else but it's not very often that I get refreshing sleep and I can tell a big difference on the rare occasion that I do. Another thing I found interesting was alpha wave intrusion. The new term for alpha waves is cyclic alternating pattern (CAP), type A2 and type A3. It seems that we all have alpha waves but with Fibromyalgia we have too many alpha waves and they are too frequent. This is what interrupts our sleep. 

Yes, it's Flexeril.

But, it's not the same old dosage.....

and it's used in another formulation.

I think it should be given a chance to prove itself.

Let's not jump on the bandwagon and trash it until we know.

Just sayin'..................

It could be an important piece of the puzzle.


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