-- 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.|
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