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Anesiva Phase 3 Trial of Adlea Meets Primary Endpoint to Significantly Reduce Pain After Total Knee Replacement Surgery
Date:12/16/2008

hieve our goal of operating largely as a virtual company by year-end," Mr. Kranda said. "We now have retained a dedicated team ideally suited for Adlea clinical development and partnering within a cost structure that is appropriate for the current environment. With these positive developments, we look forward to rebuilding value for Anesiva through our virtual model, and through active partnering and licensing programs."

ACTIVE-2 Details

This multicenter, double-blind, placebo-controlled trial enrolled 217 patients undergoing total knee arthroplasty. Patients were randomized to receive either a single 60 mL dose of Adlea (0.25 mg/mL drug concentration) or placebo instilled into the surgical site immediately prior to wound closure. The primary efficacy endpoint was the area under the curve of patient pain scores, using a standard 0 to 10 numerical weighting system from four to 48 hours post-surgery. The study also evaluated rescue opioid consumption. Additional patient safety follow-up at two to six weeks after surgery demonstrated an advantage in pain management for Adlea versus placebo, with a similar safety profile.

Adlea Phase 3 Results in Bunionectomy Surgeries

A previous Phase 3 trial of Adlea, ACTIVE-1, in bunionectomy surgeries, demonstrated a highly statistically significant reduction in pain (p=0.004) from 4 to 48 hours post-surgery for Adlea-treated patients versus placebo, although the primary endpoint, pain at 4 to 32 hours post-surgery, narrowly failed to achieve statistical significance (p=0.07). The trial also achieved the key secondary endpoint of reducing opioid use for Adlea versus placebo (p=0.012) over the four to 32 hour period, and Adlea was well-tolerated.

How Adlea May Address the Need for Long-Acting Pain Relief

Adlea is a highly purified form of capsaicin (derived from chili peppers) that acts on TRPV1 receptors, expressed most densel
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SOURCE Anesiva, Inc.
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