EPICEPT COMPLETES ENROLLMENT PAIN PATCH TRIAL

EpiCept announced that patient enrollment has been completed for its multicenter, randomized, double-blind, placebo-controlled, Phase III trial in Europe for LidoPAIN SP (lidocaine).

The product is a sterile prescription analgesic patch designed to provide sustained topical delivery of lidocaine to a post-surgical or post-traumatic sutured wound while also providing a sterile protective covering for the wound. Currently, there is no marketed product similar to LidoPAIN SP.

The potential applications for the product may include both inpatient and ambulatory surgical procedures: hernia repair, plastic surgery, puncture wounds, biopsy, cardiac catheterization and tumor removal.

The clinical trial involved 569 subjects who underwent hernia repair and received one 9.5 percent patch or a placebo patch for 48 hours. The primary endpoints are self-assessed pain intensity at various times from four to 24 hours as well as rescue medication. The secondary endpoints include pain intensity over the 48-hour duration of the study and global satisfaction among others.