The use of topically applied anesthetics presents numerous advantages over local injection such as eliminating the patient's pain and fear associated with needle injection, avoiding the risk of introducing infection, reducing the occupational risk of unintentional needle sticks, and limiting first-pass metabolism. To date, the most widely used method of topical anesthesia is EMLA (eutectic mixture of local anesthetics) cream. However, the use of EMLA requires application under a burdensome occlusive dressing and extended periods of contact before becoming effective. The goal of this study is to adapt and optimize a unique, patented skin coating drug delivery system to establish effective delivery of local anesthetics via topical administration. In order to demonstrate the feasibility of this approach, the Specific Aims are to optimize the coating to deliver topical anesthetics, to determine the in vitro percutaneous absorption of local anesthetics released from coatings, to demonstrate the safety of coatings in an animal model, and to evaluate the coatings for efficacy in a pilot human clinical trial.
The number of procedures requiring local anesthesia and the extent to which local anesthetics are being used is steadily increasing. Significant commercial potential exists for a topical anesthetic drug delivery vehicle that would combine cost effective treatment with improved convenience characteristics.
