Under the agreement, Adolor is responsible for conducting clinical trials, managing the approval process and, upon receipt of marketing approval, commercializing the product in North America.
“If LidoPAIN SP is approved, we believe that it will be the first sterile prescription analgesic patch on the market,” said Jack Talley, CEO of EpiCept. “LidoPAIN SP may also reduce the need for systemically-delivered narcotic analgesics and NSAIDs. The initiation of the phase II study by Adolor marks an important milestone in the advancement of our pipeline in the US”
Epicept is currently conducting its own pivotal scale phase III trial of LidoPAIN SP in Europe, the primary endpoint of which is self-assessed pain intensity at various times from four to 24 hours.