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news.Tonix Pharmaceuticals has completed a pharmacokinetic (PK) study of its lead drug, TNX-102, used for the treatment of fibromyalgia syndrome (FM).
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The cross-over randomized PK study enrolled 30 healthy subjects and were given either TNX-102 2.4mg promicellar gelcap or Flexeril 5mg immediate release cyclobenzaprine.
The study conducted in Canada under a US Investigational New Drug Application assessed the blood levels of cyclobenzaprine after oral administration of the TNX-102 in a fasting state.
Both TNX-102 and cyclobenzaprine were well-tolerated without showing any serious and/or unexpected adverse events.
The new formulation preserved fundamental properties of the tablet including the rate of absorption and elimination of cyclobenzaprine.
Tonix chairman and president Seth Lederman said the study data provided valuable insights which will enable the company to further advance its development programs targeting Fibromyalgia and other challenging disorders of the central nervous system.
"The core technology underlying TNX-102 improves the quality of sleep in patients with fibromyalgia and perhaps other chronic pain syndromes," Lederman added.
"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."