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Anesiva Commences Phase 2 Trial of Adlea(TM) in Arthroscopic Shoulder Surgery
Date:7/17/2008

demy of Orthopedic Surgeons, about six million Americans go to the doctor each year for shoulder pain, dislocation, or other shoulder problems and up to 500,000 arthroscopic shoulder surgeries are performed in the United States each year.

This multicenter, randomized, double-blind, dose-escalating, placebo-controlled study is evaluating the safety, tolerability, efficacy, and pharmacokinetics of a single dose of Adlea administered via injection following surgical closure of the wound. The trial is designed to enroll 74 patients.

Anesiva announced approval of its investigational new drug application for Adlea in South Korea in June 2008.

How Adlea May Address the Need for Long-Duration, Well-Tolerated Pain Relief

Adlea is a long-acting, non-opioid drug with the potential to provide pain relief for weeks to months after a single localized treatment. Its novel mechanism of action results in site-specific analgesia, which has the potential to reduce the use of and minimize the side effects associated with systemically administered analgesic drugs, such as opioids and NSAIDs.

Adlea is a highly purified form of capsaicin (derived from chili peppers) that acts primarily on C-fiber neurons, which transmit long-term pain, by binding to and desensitizing the TRPV1 pain receptors. This leads to a prolonged, reversible and localized desensitization of the pain fibers. The drug generally has a short half-life of 1 to 2 hours, and is undetectable in the blood after 24 hours.

Adlea's short duration of systemic exposure relative to the longer duration of analgesia may offer a safe, additive treatment option in the management of post-surgical orthopedic pain, as well as pain due to moderate to severe osteoarthritis. In clinical trials to date, adverse events have been similar in patients receiving Adlea or placebo.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company th
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SOURCE Anesiva, Inc.
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