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
|SOURCE Anesiva, Inc.|
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