The multicenter, double-blind, placebo-controlled trial will evaluate the efficacy and safety of Adlea in reducing post-surgical pain in patients undergoing a bunionectomy procedure. The trial, to be conducted in the US, will enroll approximately 300 patients undergoing bunionectomy surgery. Patients will be randomized to receive either a single 1mg dose of Adlea or placebo into the surgical site prior to closure. The primary efficacy endpoint is a time-weighted pain score (using a standard 0 – 10 numerical rating system of pain intensity) from four to 32 hours post-surgery.
The study will also evaluate rescue opioid consumption at prespecified timepoints during the first two weeks following surgery. Additional patient follow-up will occur at two and four weeks after surgery. The safety of Adlea in this setting will be evaluated. Top-line data from the Adlea Phase III trials are expected by the end of 2008.
John McLaughlin, CEO of Anesiva, said: “We plan to initiate an additional Phase III trial evaluating Adlea in patients undergoing total knee replacement surgery as part of an initial registration strategy for the use of Adlea in the management of pain following orthopedic surgeries.”