It is the purpose of this Phase I program to demonstrate the practical feasibility of transdermal analgesic therapy based on buprenorphine, a potent opioid already used intravenously and intramuscularly for the relief of moderate to severe pain. Preliminary in vitro experiments have confirmed that buprenorphine can pass through human skin at potentially therapeutic rates. Using BIOTEK's patented DermaPatch transdermal system it should be possible to develop small analgesic patches based on buprenorphine, one of the most benign of the opioid analgesics. Phase I will prepare candidate formulations, optimize their in vitro performance using stratum corneum from human breast skin, and test blood levels and skin irritation of patches containing the best formulation on rabbits. Successful completion of Phase I will lead to a Phase II devoted to the documentary, clinical, regulatory and licensing steps required for successful commercialization of a new transdermal product.
