The blinded comparison study had evaluated the performance of Prelude prior to the application of OTC 4% lidocaine cream for local analgesia and demonstrated remarkable improvement and an abbreviated onset of action.
Echo Therapeutics, as a result of the clinical trial, expects to submit 510(k) premarket notification to the US Food and Drug Administration in the near future.
Echo Therapeutics CEO, president and board chairman Patrick Mooney said that they are very pleased with the results of this clinical trial, and look forward to the upcoming submission of the 510(k) to the FDA for purposes of achieving market clearance, clearing the path for the launch of this product.
“In addition, regulatory clearance would result in a $750,000 milestone payment from our partner, Ferndale Pharma Group, as well the initiation of royalty revenues from the sale of the product,” Mooney said.
“The use of Prelude to enhance the action of topical lidocaine represents the best near-term revenue opportunity for Echo Therapeutics and we are excited to have achieved these exceptional results today.”
