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Anesiva Commences Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Bunionectomy
Date:3/25/2008

tients required rescue medication relative to placebo. Evaluations in other dose groups favored Adlea over placebo. Adlea was well tolerated in these studies and adverse events were comparable for placebo and Adlea treated patients.

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 just a single localized treatment. Its novel mechanism of action results in site-specific efficacy intended to avoid the unwanted side effects associated with systemically administered analagesic drugs.

Adlea is a highly purified form of capsaicin (derived from chili peppers) that acts on C nerve fibers, 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. It is undetectable in blood sample analyses after 24 hours.

Adlea's short duration of systemic exposure (hours) relative to the long duration of analgesia (weeks to months) may offer a safe, additive treatment option in the management of post-surgical orthopedic pain. Importantly, the prolonged analgesic effect resulting from localized administration of Adlea does not seem to be associated with the systemic side effects commonly associated with opioids (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence, and the risk of addiction), or with NSAIDs (gastrointestinal and renal toxicities, and impaired clotting) or COX-2 inhibitors (cardiovascular risks and renal toxicity).

Adlea is also in clinical development for the treatment of pain associated with moderate to severe osteoarthritis. In an exploratory trial in this setting, Adlea provided sustained pain reduction as compared to baseline over the twelve week study period.

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