An old drug in a new form is moving forward through trials, and the manufacturer hopes it will eventually be approved for treating fibromyalgia.
TONIX Pharmaceticals has announced that it's completed an early phase of testing for what's being called TNX-102. (This name is a research designation and, if the drug is successful, will eventually be replaced.)
TNX-102 is a combination of:
- Very Low-Dose Cyclobenzaprine: the drug in the muscle relaxant Flexeril, which a recent study suggests may improve sleep and other core symptoms of fibromyalgia when taken at bedtime in very low doses;
- Lipids: naturally occurring substances in your cells that help with energy storage, signaling, and the structure of membranes.
The TONIX study involved 30 healthy subjects who took the medication at bedtime. It was meant only to gauge how the body processed the new formulation. Noting no severe or unexpected side effects, the company now plans to move forward with further development and testing.
In a press release, Chairman and President of TONIX said, "The results of this study provide us with valuable insights which will enable us to further advance our development programs targeting fibromyalgia and other challenging disorders of the central nervous system.... We are developing TNX-102 to be a fundamental advance in sleep hygiene and pain management and to be safer and more effective than currently available treatments."
The press release points out that disturbed sleep is a core feature of fibromyalgia and yet no "bedtime medication" is approved for it.
The road to FDA approval is long and complicated, meaning that even if all goes well, TNX-102 is unlikely to be on the market for several years.
However, cyclobenzaprine already is prescribed off-label for some people with fibromyalgia, especially when muscle spasms are a serious problem.
Have you taken cyclobenzaprine? Has it helped with your symptoms? Does it improve your sleep? Leave your comments below!
Photo © Adam Gault/Getty Images