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 that was taking place and had written about it previously so I was thrilled that I had been given this opportunity.
I 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, 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. When I heard about the clinical trial, I was hoping I could be a part of it.
What is it?
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.
So what did I do?
I missed the first call.
In my defense, we didn't make it clear what time zone we were using. So after apologizing over and over again we finally settled on 9:00 Las Vegas time. I felt like SUCH an idiot but it worked out and the call came.
What a wonderful conversation! I expected a few moments. After all, this man is extremely busy so when he kept answering questions and offering information I was floored. We actually spoke for 45 minutes.
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.
I found it interesting that these two disorders could be related. PTSD, however, deals with the trauma and the lack of sleep in nightmares. Fibromyalgia has non-refreshing sleep but the trauma doesn't usually have the nightmare outlet.
Another thing I found interesting was when I asked him about 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.
I also asked about the use of Flerxil. Cyclobenzaprine (Flexeril) is an FDA approved drug that treats the muscle spasms that is associated with musculoskeletal conditions like Fibromyalgia. 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!
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. This trial is a 12 week, randomized, double blind study.
This study has approximately 120 patients taking either a tab or placebo at bedtime for twelve weeks and then measuring the change in pain intensity. The trial is fully enrolled and will report the top line results early in the 4th quarter. It will meausre reduction of pain, fatigue and mood. The study chair for this trial is Dr. Daniel Clauw, Professor of Anesthesiology, Medicine and Psychiatry and Director of the Chronic Pain and Fatigue Research Center at the University of Michigan.
We're about 100 days out from finding out what has come out of the trial.
To me, it can't come soon enough.
I have to mention one other thing about Dr. Lederman. He was a rheumatolgist and had a practice.
Then, in his words, committed "professional suicide" by going into Fibromyalgia research.
How many people would leave a thriving practice to research Fibromyalgia?
And this man is passionate about helping those with CNS (central nervous system) disorders.
After speaking with him?
I was more than impressed.
He listens. Really, really listens.
All I can say.........
His patients must REALLY miss him.