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Fibromyalgia patients take drug 'off-label' to help them sleep

Sunday 15 December 2013


From the National Pain Report:


Tension headache

Fibromyalgia Patients Take Drug ‘Off-Label’ to Help Them Sleep

November 22nd, 2013 by Pat Anson, Editor

Getting a good night’s sleep is one of the many problems faced by people with fibromyalgia.

They may be fatigued and worn out from dealing with chronic pain – but many find that sleeping soundly through the night is nearly impossible.

“I have had several, months-long stints of horrible insomnia,” says Benia Zouras, who often woke up at 2 am and was unable to fall asleep again for several hours. Like many other fibromyalgia patients, she tried Lyrica, Cymbalta, Savella, and opioid pain medicines; and found they didn’t work or had unwelcome side effects.

“Oh my goodness, I was a wreck! I zombied my way through so many work days,” Zouras says of her sleepless nights. “I hope that never happens again!”

It hasn’t happened again, thanks to a generic drug that she started taking off-label over a year ago.

Cyclobenzaprine is a muscle relaxant, not a sleep aid, and is not approved by the Food and Drug Administration as a treatment for fibromyalgia. But many fibromyalgia patents have learned through sympathetic doctors and word of mouth that the drug can help them get that elusive good night’s sleep.

“Since starting on the cyclobenzaprine, I’ve been getting pretty good sleep reliably, with very few exceptions,” says Zouras, who also suffers from muscle spasms caused by chronic myofascial pain.

“Although it does not relieve me of my spasms or prevent pain entirely, it is a tool that I believe helps, and even if it only helps me sleep, that is still valuable in my treatment plan.”

Others have taken note of the relief fibromyalgia patients are getting from cyclobenzaprine, which is often sold under the brand name Flexeril. Tonix Pharmaceuticals (NASDAQ: TNXP), a drug development company based in New York City, has created a new formulation of cyclobenzaprine that it claims is superior to the generic version.

The drug, which for now is being called TNX-102, is a low dose, rapid release version of cyclobenzaprine that is designed to be taken at bedtime.

“The branded drug that we’re doing is a very significant improvement over what the generic product can do. The generic dose is too high for a bedtime medicine and it’s not approved for chronic use,” says Seth Lederman, MD, a rheumatologist who is the CEO and co-founder of Tonix.

“I have direct experience taking care of fibromyalgia patients. The only reason I got involved in this and have devoted the past five years to it full time is that what I think we’re bringing to patients is a very important new treatment option.”

In a small Phase II clinical study, TNX-102 not only helped fibromyalgia patients sleep through the night, it improved their symptoms of pain, tenderness, fatigue, and depression throughout the day.

Tonix recently began a second Phase II study involving 120 fibromyalgia patients, but results are not expected until late 2014. Even if the results are good, a Phase III study will then be necessary to satisfy the FDA’s long approval process for new drugs.

Lederman is hopeful TNX-102 will win approval from the FDA in 2017 – not as a sleep aid – but as a front line treatment for both fibromyalgia and post-traumatic stress disorder (PTSD).

Why should fibromyalgia patients wait that long – when a generic version of the drug is already available?

“It’s really challenging for patients to use the generic. I think that what we’re bringing is a very significant improvement,” Lederman told National Pain Report.

“If someone is going to use cyclobenzaprine off-label to get the effect that we’re getting, they really have to go through an elaborate scheme with the patient to tell the patient to cut the tablet in half and take it two hours before bedtime. That’s a very difficult treatment regimen for someone to incorporate into their daily lives.”

It’s a regimen that Benia Zouras is more than happy to have. She takes two 10 mg tablets of cyclobenzaprine nightly – a very high dose compared to TNX-102. Other than drowsiness, Zouras has no other side effects and has stopped taking all other medications.

“As I told my doctor, I prefer to minimize the number of medications I put into my body, especially if there is little or no improvement in symptoms, so I was happy with this approach of trying one drug to do two things. I was even happier when I was able to confirm that it actually did help me sleep and helped with muscle spasms,” says Zouras, who writes about fibromyalgia on her blog.

“In addition to taking this medication, I strive to eat healthy and stay active and at least stretch my muscles daily to try to prevent problems with them. I still live in pain, but making these decisions about my health do help me to feel like I have some control over my life, which makes a big difference in tolerating the lifestyle changes I bear to live with my health conditions.”

The potential market for TNX-102 is huge. According to the National Institutes of Health, about five million Americans suffer from fibromyalgia – although some estimate the number could be two or three times higher.

Post-traumatic stress disorder affects another 77 million Americans, many of whom suffer from insomnia, anxiety, depression and other symptoms similar to fibromyalgia.


The above originally appeared here.


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