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Anesiva Defines Regulatory Pathway for Adlea with FDA
Date:10/10/2007

essary for sensory or motor sensations and proprioception.

Pharmacokinetic studies of Adlea showed that when it is locally administered to the site of pain, there appears to be limited systemic exposure. Its short duration of systemic exposure (hours) relative to the long duration of analgesia (weeks to months) resulting from a single treatment of Adlea is particularly important in this typically elderly and vulnerable patient population and may also potentially offer a safer treatment option in the management of chronic osteoarthritis pain. Importantly, the prolonged analgesic effect resulting from a single or stepped dose, localized administration of Adlea does not seem to be associated with the systemic side effects commonly associated with NSAIDs (gastrointestinal and renal toxicities, and impaired clotting), COX-2 inhibitors (cardiovascular risks and renal toxicity), or opiates (respiratory depression, nausea/vomiting, sedation, disorientation, physical dependence, and the risk of addiction). In clinical studies to date, Adlea has been shown to be well tolerated.

About Bunionectomy Surgeries

A bunionectomy is a surgical procedure to align the bones of the big toe joint thereby excising the bunion. A bunion is an enlargement of the joint at the base of the big toe caused by the misalignment of the big toe joint. It is usually a result of inflammation and irritation from poorly fitting (narrow and tight) shoes and is a condition that can be exacerbated by excessive standing or running. Bunionectomies are often performed as out-patient procedures enabling patients to go home the same day of their surgery.

About Anesiva and its Diverse Portfolio of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has one FDA-approved product, Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal in
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SOURCE Anesiva, Inc.
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