Echo Therapeutics Inc. (OTC:ECTE) and Ferndale Pharma Group Inc. enrolled the first patients in a clinical trial of Echo’s Prelude SkinPrep device and Ferndale’s 4 percent topical lidocaine, ahead of an application for 510(k) clearance for the drug-device combo from the Food & Drug Administration.
Franklin, Mass.-based Echo’s Prelude device is a needle-free, transdermal drug delivery system that ablates a thin layer of skin before a drug is applied.
In January the company said it was nearly ready to launch the clinical trial, having completed its development work on the product. The trial is designed to "evaluate the ability of the Prelude SkinPrep System to ablate the skin prior to application of OTC 4 percent lidocaine cream for local dermal anesthesia," according to a press release. Once it’s complete the companies plan to submit the 510(k) application to the FDA, likely later this year.
Echo said it licensed the rights to develop and commercialize the Prelude in the U.S. and the U.K. to Ferndale in May 2009, for an up-front payment of $750,000. Once the device wins FDA clearance another $750,000 milestone payment is due, plus $12.5 million "in milestone payments and guaranteed minimum royalty payments" and ongoing royalties on net sales, according to the release.
Echo chairman and president Dr. Patrick Mooney estimated in prepared remarks that the topical anesthetic market is worth more than $200 million a year and that the Prelude device "has the potential to grow it significantly."
Echo is also nearing readiness for a clinical trial of its Symphony tCGM transdermal glucose monitor, after a design breakthrough reduced the size of the device’s electrical component by a third.