The biotech company’s sterile patch contains a concentration of sustained-release lidocaine. Under the protocol, investigators apply the patch directly over the incision upon closing and leave the patch in place for 72 hours. The patch is intended for use in both hospital and outpatient surgical settings.
The phase II multicenter study is expected to enroll 30 patients undergoing hernia repair surgery. The study’s primary objective is to evaluate the pharmacokinetics of this investigational new product. Safety and tolerability will be evaluated for up to 72 hours, and preliminary efficacy data will be obtained to assess the analgesic effect during the 72-hour treatment period.
“Unlike any of the products currently on the market, the patch is applied in the operating room, directly on the incision after surgery. The objective here is to eliminate any potential lapse in pain control from the time local anesthetic wears off, to the time the lidocaine patch takes effect,” said Dr James Barrett, senior vice president and president of research at Adolor.
The company intends to perform additional studies in hernia repair surgery as well as other surgical procedures to support product registration. In 2003, Adolor in-licensed the North American rights to develop and market the sterile lidocaine patch from EpiCept.