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Anesiva Announces Second Quarter 2008 Financial Results and Update

conduct training sessions for selected healthcare providers to advocate for better venous access pain management for their pediatric patients, to grow membership in RNVoice, and to experience increased visits to"

-- The FDA accepted Anesiva's electronic sNDA filing to expand the Zingo

label indication to include adults. Under the Prescription Drug User

Fee Act (PDUFA), the agency is expected to make a decision regarding

approval by January 2009.

-- The journal Pediatrics published full results of one of the two pivotal

Phase 3 pediatric trials of Zingo.

-- Anesiva signed an exclusive Zingo licensing and distribution agreement

with Green Vision Company for territories in the Middle East, and

expanded the territories covered under the license and distribution

agreement with Sigma Tau SpA to include most of Europe.


-- During the second quarter, Phase 3 enrollment began in a trial of Adlea

for the management of acute pain following total knee replacement

surgery. This multicenter, double-blind, placebo-controlled study will

evaluate the efficacy and safety of a single dose of Adlea or placebo

administered prior to closure of the surgical wound. Total planned

enrollment is 214 patients. Enrollment continued in a 300 patient Phase

3 trial of Adlea in patients undergoing bunionectomy surgery.

-- Anesiva initiated a Phase 2 trial with Adlea for the management of

acute pain following arthroscopic shoulder surgery. Total planned

enrollment in this multicenter, double-blind, dose-escalation, placebo-

controlled trial is 74 patients.

-- Several Adlea posters will be presented at the upcoming World Congress

on Pain, a major international meeting to be held August 17-22, 2008.


SOURCE Anesiva, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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