Echo Therapeutics Inc., a Massachusetts based medical device and specialty pharmaceuticals company, announced today that they have completed product development of their revolutionary PreludeTM SkinPrep System. The product will now go into final clinical trials, and, subject to FDA market clearance, the product will be sold commercially with no further changes.
The Prelude SkinPrep System is a skin preparation platform technology used for needle-free transdermal drug delivery, designed for use with novel topical reformulations of widely used FDA approved products. Prelude will be tested using LMX4 lidocaine cream, which should form the basis for a 510-K filing with Ferndale Pharma Group for the enhanced delivery of lidocaine. Echo believes that the market for enhanced fast-acting topical lidocaine exceeds $1 billion.
In addition, Prelude will be tested in the near future for skin preparation prior to application of a biosensor used with the company’s SymphonyTM tCGM (transdermal continuous glucose monitoring) System. Symphony is a wireless needle-free glucose monitoring system for use by patients with diabetes and critically ill patients who require aggressive glucose monitoring. Prelude incorporates Echo’s patented skin permeation control feedback technology into a comfortable, wireless, hand-held device, used to prepare a small area of the skin for the biosensor and monitoring components of Symphony.
Echo’s chairman and CEO, Patrick Mooney, M.D., said, “We are now prepared to complete our clinical validation and begin commercialization efforts in enhanced topical lidocaine delivery. This next generation skin preparation device incorporates substantial improvements beyond the prototype used in earlier studies. We anticipate testing Prelude with LMX4 anesthetic cream for enhanced local dermal anesthesia in the near-term and subsequently seeking 510-k market clearance from the FDA.”
As part of its ongoing development program, Echo is leveraging its AzoneTSTM skin ablation technology to develop a wide-variety of new transdermal reformulations of pharmaceutical products already approved by the FDA. Echo has submitted a New Drug Application (NDA) to the FDA covering its lead AzoneTS-reformulated product candidate, DurhalieveTM, for treatment of corticosteroid responsive dermatoses. Echo is also focused on Phase 2 development of Durhalieve for keloid scarring. Echo is developing additional AzoneTSTM product candidates in accordance with the FDA’s Section 505(b)(2) guidelines.