Anesiva Initiates Phase 2 Trial with Adlea(TM) for Pain Relief Following Total Hip Replaceme... (lationon the first post-operative day an...)

Anesiva Initiates Phase 2 Trial with Adlea(TM) for Pain Relief Following Total Hip Replacement Surgery

Date:10/4/2007

lation on the first post-operative day and significantly less pain on follow-up visits at two weeks. Adlea-treated patients also had numerically lower mean pain scores at pre-specified time intervals over the first two weeks post-surgery in the study while pharmacokinetic data demonstrated that most patients (19 of 25) had detectable plasma Adlea levels for less than 12 hours (presented at the American Pain Society meeting in May 2007). This short duration of systemic exposure associated with the long duration of pain relief following a single Adlea dose may potentially represent a huge advantage in risk-benefit ratio with Adlea use relative to the conventional systemically active analgesics on the market. As expected, the study also met its primary objective of demonstrating safety and tolerability.

Anesiva's goal is to initiate 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 arthroscopic shoulder surgery, a Phase 2 / 3 trial in osteoarthritis of the knee, and a Phase 3 trial in Total Knee Arthroplasty (TKA). Anesiva also recently initiated a Phase 2 trial in TKA.

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 necessary for sensory or motor sensations and proprioception.

Pharmacokinetic studies of Adlea showed that when it is locally administered to the site of pain, t
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