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news.Phosphagenics, a biotechnology company, has announced the successful completion of a Phase I clinical trial that examined the ability of its patented drug delivery system, TPM, to topically deliver the pain relief drug, lidocaine, safely into humans.
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The trial demonstrated that the patented lidocaine formulation was able to deliver a significantly greater amount of lidocaine into the localized area of the skin compared to a leading commercial product.
This clinical trial compared the dermal penetration and measured the systemic exposure of lidocaine between one of the leading marketed products, Xylocaine (5% lidocaine), and Phosphagenics’s TPM/lidocaine (5% lidocaine).
Approximately one hour after application, TPM/lidocaine delivered 500% more (p<0.001) lidocaine into the stratum corneum, the outer layer of the skin, than the commercial product, Xylocaine. Phosphagenics's TPM/lidocaine also augmented the depth of penetration, with 450% (p<0.01) more lidocaine found in the deepest layers of the skin sampled. According to the company, TPM/lidocaine significantly increased the amount, rate, and depth of lidocaine penetration into the skin compared to Xylocaine, 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 after six hours. Esra Ogru, executive vice president of R&D at Phosphagenics, said: "While we have previously demonstrated the penetrative power of our TPM technology, the success of this trial validates the versatility and precision of Phosphagenics's drug delivery platform in humans. We view this as a major achievement for our company and look forward to moving ahead with further clinical trials."