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Anesiva Announces Phase 2 Data Showing Substantial, Long-Term Pain,Reductions with Adlea(TM) (formerly 4975) in Osteoarthritis of the,Knee

n or stepped doses leads to pain relief durable for 12 weeks in patients suffering from moderate to severe pain due to knee osteoarthritis.

The following table summarizes the reduction in pain scores provided by the use of Adlea compared to baseline pain scores. A scale of 0-4 (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain and 4 = extreme pain) was used in the study:

                                -- Weeks Following Adlea Treatment --


                       Baseline       1            8           12

                        (n=54)      (n=51)       (n=54)      (n=50)

    Average Pain

     Score               2.22        0.86         0.79        0.74


    Percentage

     Reduction from

     Baseline             N.A.         61%          64%         65%

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

Adlea is long-acting, with the potential to provide pain relief for weeks or months after just a single localized treatment. It is a non-opioid TRPV1 agonist with a unique mechanism of action that provides a long-lasting, localized effect on C-fibers and blocks the transmission of aching, throbbing pain caused by major surgical procedures and end-stage osteoarthritis. Because it selectively acts on pain-sensing nerve endings, Adlea does not affect other nerve fibers necessary for sensory or motor sensations, such as those needed to sense temperature or pressure. In clinical studies to date, Adlea has not had the side effects often associated with other conventional pain medications and has been shown to be well tolerated.

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 (12 weeks) resulting from a single treatment course of Adlea is particularly
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