Anesiva Commences Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Bu...(r pain medications. The trial to be ...),Health

The trial, to be conducted in the U.S., will enroll approximately 300 patients undergoing bunionectomy surgery. Patients will be randomized to receive either a single 1.0 mg 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.

"We are encouraged by the positive results Adlea has already shown in mid-stage clinical trials for pain management following various surgeries, including bunionectomy. We are optimistic that this Phase 3 trial will further demonstrate Adlea's effectiveness in a multi-modal therapeutic regimen for post-surgical pain," said John P. McLaughlin, chief executive officer of Anesiva. "We plan to initiate an additional Phase 3 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." Top-line data from the Adlea Phase 3 trials are expected by year-end 2008.

Two prior randomized, double-blind, placebo-controlled Phase 2 bunionectomy trials evaluating the use of Adlea to reduce post-surgical pain yielded favorable results. The first was an exploratory study that suggested Adlea at the 1.0 mg dose level to be used in the Phase 3 trial was active relative to placebo. A larger (n=185) Phase 2 trial evaluated three dose levels of Adlea versus placebo. Dose response was demonstrated and, at the 1.0 mg dose level, the Adlea-treated group demonstrated statistically significantly less pain following surgery, and a significantly lower proportion of pa
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