Positive Phase 1 Clinical Trial Results for Transdermal Lidocaine
Trial Demonstrates Increased Dermal Penetration of TPM/Lidocaine Compared to Topical Anaesthetic Xylocaine(R)
Lidocaine is a well known topical anaesthetic, sales of which exceeded US
One hour after application, TPM/lidocaine delivered 500 percent more (p<0.001) lidocaine into the stratum corneum, the outer layer of the skin, than the commercial product, Xylocaine(R). Phosphagenics' TPM/lidocaine also augmented the depth of penetration, with 450 percent (p<0.01) more lidocaine found in the deepest layers of the skin sampled.
TPM/lidocaine significantly increased the amount, rate, and depth of lidocaine penetration into the skin compared to Xylocaine(R), parameters that are normally expected to produce a local analgesic effect. Despite the increase in dermal drug delivery, TPM/lidocaine did not increase the plasma lidocaine concentration compared to Xylocaine(R) after 6 hours.
The open label, single centre study was conducted at the Centre for Pharmaceutical Research, University of
APPENDIX AND NOTES TO EDITORS
About Phosphagenics Limited
Phosphagenics is a
Phosphagenics' core technology is built around the science and application of phosphorylation, a process where the addition of a phosphate group has been found to enhance the bioavailability, activity and safety of existing pharmaceuticals and nutraceuticals, as well as to assist in the production of drug delivery platforms.
Phosphagenics' shares are listed on the Australian Stock Exchange (POH) and the London Stock Exchange's Alternative Investment Market (PSG). An ADR - Level 1 program was established in the U.S. with The Bank of New York Mellon (PPGNY) for U.S. investors to trade in Phosphagenics' stock on the 'over-the-counter' market. In
For more information, please visit Phosphagenics' web site at www.phosphagenics.com
Safe Harbor Statement
This press release contains forward-looking statements based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialise, actual results could vary materially from the Phosphagenics' expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations.
SOURCE Phosphagenics Limited