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news.EpiCept Corporation has completed patient enrollment in its European phase III pivotal trial evaluating its analgesic patch, LidoPAIN SP.
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LidoPAIN SP 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 phase III clinical trial is a randomized, double-blind, placebo-controlled trial in which 569 subjects who underwent hernia repair received one 9.5% LidoPAIN SP 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.
This study follows a phase II trial that EpiCept initiated in December 2001. This trial evaluated 221 subjects who underwent hernia repair, with subjects were randomized to receive two different doses of lidocaine, 9.5% and 3.5%, or placebo, in a patch applied once each day for two days. Results indicated that the 9.5% formulation of LidoPAIN SP provided an analgesic effect in the patients. A dose-related response was also observed, with subjects receiving the higher dose reporting a greater reduction in pain and fewer rescues.
EpiCept said that it anticipates being able to report results from the phase III trial before September, and believes the trial should support a marketing application for LidoPAIN SP in Europe.