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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

SOUTH SAN FRANCISCO, Calif., April 8, 2008 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that a pivotal Phase 3 clinical trial evaluating Adlea(TM), its long-acting, non-opioid analgesic drug candidate, in patients following total knee replacement surgery, is underway.

In September 2007, Anesiva initiated a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial to evaluate the safety and efficacy of a single 5 or 15 mg dose of Adlea or placebo administered into the surgical site in patients undergoing total knee replacement surgery. Having completed enrollment of the initially planned 80 patients, Anesiva has converted this trial into a Phase 3 trial by expanding the planned enrollment by approximately 134 patients for a total sample size of 214, increasing the number of trial sites, and focusing enrollment on the 15 mg and placebo groups.

"Total knee replacement is a commonly performed orthopedic surgery that can significantly enhance patients' quality of life," said Keith Candiotti, M.D., Associate Professor of Clinical Anesthesiology and Internal Medicine; Director of Clinical Research, Chief, Division of Perioperative Medicine, University of Miami Leonard M. Miller School of Medicine, and investigator in the Phase 3 study. "The effective management of post-surgical pain is critical since patients must begin walking and moving the knee soon after the procedure in order to begin recovery and avoid complications. Adlea may offer additive pain relief and possibly reduce the use of other pain medications such as opioids, whose systemic side effects can interfere with the recovery process."

The primary efficacy endpoint of the Phase 3 trial is a time-weighted pain score (using a
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SOURCE Anesiva, Inc.
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