| Indication | Relief of moderate pain due to surgical incision |
| Target Population | 50+ million surgeries annually |
| Description | Sterile lidocaine hydrogel patch |
| Dosage and Administration | Once daily placed on surgical incision |
| Adverse Reactions | Mild, transient redness |
| Experience | Over 570 patients treated in four clinical trials |
Description
LidoPAIN SP is a sterile prescription analgesic patch designed to provide sustained topical delivery of lidocaine to a post-surgical incision or post-traumatic sutured wound in order to relieve post-operative pain and minimize the need for systemic administration of narcotics, NSAIDS or Cox II inhibitors. More than 53 million surgical procedures are conducted annually in the U.S. and many, if not most, of these procedures are candidates for LidoPAIN SP.
Stage of Development
On September 5, 2006, EpiCept announced that a Phase III trial for LidoPAIN SP in Europe did not meet its co-primary endpoints of self-assessed pain intensity between 4 and 24 hours and patient use of “rescue” medications. EpiCept is in the process of conducting a thorough analysis of the trial results in order to determine what changes in trial design could be made to improve the likelihood of a positive result in a subsequent trial. The principal reason for this trial outcome is believed to be subcutaneous lidocaine injection into the open wound by surgeons prior to skin closure. This exogenous lidocaine confounded the ability of the lidocaine on the patch to show a therapeutic effect. EpiCept will continue to share the results of this analysis as they become available.