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Anesiva Defines Regulatory Pathway for Adlea with FDA
Date:10/10/2007

New Phase 3 Plan Could Expedite Clinical Development Pathway

SOUTH SAN FRANCISCO, Calif., Oct. 10 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that it will conduct two Phase 3 clinical trials for the approval of Adlea(TM) -- one of which has already been planned in total knee replacement surgeries -- and the second trial in bunionectomy surgeries -- for a broad product label of management of post-surgical pain associated with orthopedic surgeries. This decision is the result of continuing conversations with the Food and Drug Administration (FDA). Adlea is the company's long-acting, non-opiate analgesic drug candidate designed to provide pain relief for weeks to months after a single local application during a surgical procedure. Anesiva has already demonstrated statistically significant pain reduction in Phase 2 trials in both of these settings. Both trials are expected to begin in the first half of 2008.

"We are very pleased with this agreement with the FDA. Some of our strongest clinical efficacy data for Adlea came from a Phase 2 bunionectomy trial of 185 patients, where Adlea resulted in statistically significant reductions in both post-surgical pain as well as the use of rescue medication," said John P. McLaughlin, chief executive officer of Anesiva. "Bunionectomy is an excellent choice for a second Phase 3 study because it is a well studied and validated pain model. In addition, bunionectomy studies are efficient and can be conducted rapidly."

Two prior randomized, double-blind, placebo-controlled Phase 2 bunionectomy trials evaluating the use of Adlea to reduce post-surgical pain yielded favorable results. The first trial was a Phase 2 study of 40 patients that s
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SOURCE Anesiva, Inc.
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