Epicept Corporation announced that the U.S. Food and Drug Administration has cleared the IND for LidoPAIN SP, a lidocaine-based topical hydrogel patch, to begin human clinical trials in the United States. LidoPAIN SP would be the first sterile hydrogel patch for use in ameliorating pain from surgically closed wounds if approved for marketing. Phase II U.S. efficacy trials are expected to begin in the first quarter of 2003.
"EpiCept looks forward to adding to a growing body of placebo-controlled human data which support the concept of peripheral analgesia and EpiCept's portfolio of topical pain products," stated Jack Talley, Chief Executive Officer. "Our goal is to provide novel and effective approaches for relieving pain and minimizing the use of systemic narcotics, opioids and non steroidal anti-inflammatory drugs."
Talley continued, "marketing research has told us that general surgeons would embrace a product like LidoPAIN SP, especially since this topical approach to pain relief has not yet been shown to have any of the bothersome side effects seen with the narcotics currently being used".
EpiCept has recently completed a Phase II placebo-controlled clinical trial in Europe for LidoPAIN SP. Results from this trial are expected in the first quarter of 2003. LidoPAIN SP is protected by several granted and pending composition and method of use patents in the U.S. and abroad.