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

uggested Adlea 1000ug was superior to placebo. The larger (n=185) phase 2 trial evaluated three dose levels of Adlea (100ug, 500ug and 1000ug) versus placebo. Dose response was demonstrated as follows: the Adlea 1000ug (concentration of 0.25 mg/mL) treated group demonstrated statistically significantly less pain in the first 32 hours following surgery (p = 0.0183) and a significantly lower proportion of patients requiring rescue medication (p = 0.0125) relative to placebo; the Adlea 500ug (0.125 mg/mL) treated group demonstrated a favorable trend both in pain rating and in the use of rescue medication. All three dosage levels of Adlea were shown to be well tolerated without safety concerns. In the Phase 3 program, an Adlea concentration of 0.25 mg/mL (1 mg instillation in bunionectomy and 15 mg in total knee arthroplasty) will be evaluated.

Anesiva is focused on two lead indications for Adlea: management of acute post-operative pain associated with orthopedic surgeries and management of osteoarthritis pain in the knee. Trials underway include a Phase 2 trial evaluating patients undergoing total knee and another trial in total hip replacement surgeries. Anesiva expects to initiate the following additional trials: a Phase 2 trial in arthroscopic shoulder surgery, a Phase 2 / 3 trial in osteoarthritis of the knee, and the two Phase 3 trials mentioned above for total knee replacement and bunionectomy surgeries.

How Adlea May Address The 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 nec
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SOURCE Anesiva, Inc.
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