Anesiva Initiates New Phase 2 Trial of Adlea(TM) for Pain Relief Following Knee Replaceme... (centration that has shown significantana...)

Anesiva Initiates New Phase 2 Trial of Adlea(TM) for Pain Relief Following Knee Replacement Surgery

Date:9/13/2007

centration that has shown significant analgesic efficacy in other clinical settings.

Anesiva's goal is to initiate other clinical trials of Adlea for two lead indications in the coming months: management of acute post-operative pain associated with orthopedic surgeries and management of osteoarthritis pain in the knee. These include a Phase 2 trial in total hip replacement, a Phase 2 trial in arthroscopic shoulder surgery, a Phase 2 / 3 trial in osteoarthritis of the knee and a Phase 3 trial in TKA.

How Adlea May Provide 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-opiate 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, the prolonged analgesic effect 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).

About Total Knee Arthroplasty

Total knee replacement (also known as total knee arthroplasty) is generally performed in patients with end-stage osteoarthritis of the knee. These patients have disabling pain which imposes severe limitations on their mobility, and knee replacement is performed with the goal of restoring or improving patients' quality of life. There were an estimated 470,000 total knee replacement pro
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