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Anesiva Announces Pivotal Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Total Knee Replacement
Date:4/8/2008

standard 0 - 10 numerical rating scale of pain intensity) from four to 48 hours following knee replacement surgery. The study will also evaluate pain scores during the first two weeks following surgery, as well as opioid consumption. The safety of Adlea will be evaluated throughout the study.

"We now have two pivotal Phase 3 trials in progress for Adlea, in total knee replacement surgeries and bunionectomy surgeries, and expect to have top-line data from both by year-end," said John P. McLaughlin, chief executive officer of Anesiva. "We also are conducting a Phase 2 trial in total hip replacement surgeries and plan to initiate a Phase 2 trial in arthroscopic shoulder surgeries to support a broad label of pain management following orthopedic surgery."

Anesiva has previously completed Phase 1 and 2 trials of Adlea in total knee replacement and bunionectomy surgeries, as well as in osteoarthritis of the knee, elbow tendonitis and Morton's neuroma.

About Total Knee Replacement

Total knee replacement (also known as total knee arthroplasty) is generally performed in patients with end-stage osteoarthritis of the knee. These patients have disabling pain which imposes severe limitations on their mobility, and knee replacement is performed with the goal of relieving pain and restoring mobility and knee function. There were an estimated 565,000 total knee replacement procedures performed in the United States in 2006, and the number of replacements will continue to grow as the average age of the U.S. population increases and as these individuals conduct more active lives. The American Academy of Orthopedic Surgeons projects that approximately 3.5 million of these procedures will be done each year by 2030.

How Adlea May Address the Need for Long-Duration, Well-Tolerated Pain Relief

Adlea is a long-acting, non-opioid drug with the potential to provide pain relief for weeks to months after a single localized treatment. Its novel mechanism
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SOURCE Anesiva, Inc.
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