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Tonix Pharmaceuticals Holding Corp. (OTCBB: TNXP) (“TONIX” or the “Company”), a specialty pharmaceutical company developing non-addictive treatments for chronic pain syndromes, today reports that its new sublingual (under-the-tongue) formulation of its fibromyalgia (FM) drug TNX-102 reduces the production of a problematic metabolite, according to data from a recently-completed clinical trial.
TNX-102 is the Company’s low dose form of cyclobenzaprine. Cyclobenzaprine is a drug originally approved by the Food and Drug Administration for short term treatment of acute muscle spasm several decades ago and it is currently one of the most widely prescribed off-label medications for FM. TONIX has shown that low dose cyclobenzaprine given before bedtime is effective to reduce the pain suffered by FM patients and to improve the quality of sleep. Yet when given as an oral pill on a chronic daily regimen, cyclobenzaprine can lose its effectiveness over time.
Tonix’s research sheds light on a potential cause of this problem. Tonix has discovered that a significant amount of cyclobenzaprine from oral tablets is converted into a metabolite called norcyclobenzaprine, which builds up in the body with daily dosing. Although norcyclobenzaprine had been described previously in cases of overdose, Tonix has found that the levels of norcyclobenzaprine are significant even at low doses and that norcyclobenzaprine is a psychoactive substance. Norcyclobenzaprine has a similar effect on the brain as cyclobenzaprine, so the accumulation of the metabolite over time is expected to interfere with the beneficial effects of bedtime cyclobenzaprine. Norcyclobenzaprine makes it impossible to use currently available cyclobenzaprine tablets in a chronic bedtime dosing regimen to achieve beneficial effects on the sleeping brain and still have the drug largely cleared by the next morning.
TONIX’s new sublingual formulation of cyclobenzaprine (TNX-102 SL) can significantly reduce this problem, according to the Company’s pharmacokinetic study. The study showed that levels of the norcyclobenzaprine metabolite can be reduced by using a sublingual formulation compared to oral cyclobenzaprine tablets. As a result, TNX-102 SL is a significant advance over oral tablets and is suitable for long-term treatment.