Anesiva’s Phase III pain trial meets endpoint

The trial has also met its key secondary endpoint with Adlea demonstrating a highly significant reduction in opioid medication consumption compared to placebo (p=0.005). Adlea is a non-opioid drug candidate in development for the management of acute pain following orthopedic surgery.

The Phase III total knee replacement surgery trial, known as Active-2, also showed that Adlea’s safety profile of adverse events, wound healing, and wound sensory function were similar to placebo over the study duration.

This multicenter, double-blind, placebo-controlled trial enrolled 217 patients undergoing total knee arthroplasty. Patients were randomized to receive either a single 60ml dose of Adlea (0.25mg/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, the company said.

William Houghton, chief medical officer of Anesiva, said: These compelling results confirm the analgesic contribution of Adlea during the most critical period following total knee arthroplasty with simultaneous opioid sparing effect, all without adding to the systemic side-effects commonly seen with opioids. These results suggest that Adlea has the potential to facilitate early rehabilitation in the knee replacement population.