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Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
Date:10/16/2007

Company Plans to File Supplemental New Drug Application with FDA in First

Quarter 2008

SOUTH SAN FRANCISCO, Calif., Oct. 16 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced positive top-line results from its pivotal Phase 3 trial. The multi-center, randomized, double-blind study with 699 adult patients met its primary endpoint, demonstrating less venous procedural pain in those treated with Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system compared to placebo (p= 0.003). Patients received Zingo or placebo one to three minutes prior to undergoing venous access procedures (IV insertions or blood draws). Zingo was found to be well tolerated in this patient population. Anesiva plans to file a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) in the first quarter of 2008 for the use of Zingo in adults.

"We've now shown that Zingo works in both the pediatric and adult populations. An expanded label from the FDA to include adults could greatly expand the market opportunity for us," said John P. McLaughlin, chief executive officer of Anesiva. "We have a world-class commercialization team that has significant efforts underway to prime the market for Zingo's introduction to pediatric hospitals in order to prepare for a strong launch and the development of a very successful business."

Zingo is already approved by the FDA to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children three to 18 years of age. Its onset of action is one to three minutes. Venous access procedures are among the most common procedures performed at a hospital, with more th
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SOURCE Anesiva, Inc.
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