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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

SOUTH SAN FRANCISCO, Calif., Dec. 16 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced top-line results showing that the Phase 3 trial evaluating Adlea(TM), its long-acting, non-opioid analgesic drug candidate, achieved its primary efficacy endpoint of reducing post-surgical pain versus placebo (p=0.03) following total knee arthroplasty (TKA, or total knee replacement surgery) at four to 48 hours after surgery. The trial 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 long-acting, non-opioid drug candidate in development for the management of acute pain following orthopedic surgery.

The Phase 3 TKA trial, known as ACTIVE-2 (Assessment of highly purified Capsaicin To ImproVE pain management after orthopedic surgery), also showed that Adlea's safety profile of adverse events, wound healing, and wound sensory function were similar to placebo over the study duration.

"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," said William Houghton, M.D., Anesiva's senior vice president and chief medical officer.

"The ACTIVE-2 data convincingly validate the value of the Adlea asset and will support our plans to partner or license this product candidate," said Michael L. Kranda, Anesiva's president and chief executive officer.

"Over the past several months, we have revised the company's business model to significantly reduce our burn rate, and will ac
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SOURCE Anesiva, Inc.
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