In addition, TPM/Lidocaine was able to increase the depth of lidocaine penetration. A significant (p < 0.001) increase of approximately 500% in lidocaine was detected in the thigh muscle of animals treated with TPM/Lidocaine over Xylocaine(R) alone.
Importantly, the increases in lidocaine delivery to both skin and muscle did not lead to a significant increase in systemic exposure. The average plasma lidocaine concentration peaked 1 hour after the topical application for both TPM/Lidocaine and Xylocaine(R). The differences in plasma concentration were not statistically significant. This is particularly impressive given the magnitude of the differences in the lidocaine concentrations in both skin and muscle.
These results show that TPM has the potential to be used as a targeted,
localised delivery system, capable of increased delivery of therapeutic
levels of lidocaine, and very likely other products, to targeted areas
while minimising exposure to the rest of the body.
Mean lidocaine levels in tissue and plasma following treatment
Treatment Skin Thigh Plasma Concentration
(micrograms) (micrograms) (ng/ml)
Xylocaine(R) 5% 1.47 +/- 0.65 0.11 +/- 0.03 54.17 +/- 26.22
TPM/Lidocaine 5% 13.46 +/- 2.23 0.59 +/- 0.10 77.46 +/- 38.38
Dr. Esra Ogru, Executive Vice President of Research and Development at Phosphagenics, said: "We are excited by the prospect of being a global competitor in such a large market, with global sales of topical local anesthetics for the year ended 30 June 2007 reaching U.S. $1.2 billion. Our technology has shown the potential to substantially enhance the current standard of care."
Harry Rosen, President and CEO at Phosphagenics, said "Commercially, a
portfolio of topically delivered products offers a number of ad
|SOURCE Phosphagenics Limited|
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