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Anesiva Announces Adlea ACTIVE-1 Phase 3 Clinical Results, Ceasing of Zingo Commercial Operations and Restructuring
Date:11/10/2008

V1 receptors, expressed most densely in C-fiber neurons. Importantly, desensitization of the TRPV1 receptors blocks noxious pain with no effect on adaptive pain or position sense. Adlea generally has a short half-life of 1 to 2 hours. It is undetectable in blood sample analyses after 24 hours.

Adlea's short duration of systemic exposure (hours) relative to the long duration of analgesia may offer a safe, additive treatment option in the management of orthopedic pain over the days to weeks that patients experience acute post-surgical pain. Importantly, Adlea appears to have a safety profile that is largely similar to placebo, in studies performed to date.

Adlea ACTIVE-1 Clinical Trial

The ACTIVE-1 multicenter, double-blind, placebo-controlled trial enrolled 301 patients undergoing bunionectomy surgery. Patients were randomized to receive either a single 4 mL dose of Adlea (0.25 mg/mL) or placebo instilled into the surgical site immediately prior to wound closure. The primary efficacy endpoint was a time-weighted pain score (using standard 0 to 10 numerical rating system of pain intensity) from four to 32 hours post-surgery. The study also evaluated rescue opioid consumption, pain level from four to 48 hours and multiple other secondary endpoints. The study results will be submitted for presentation at a scientific meeting.

About Anesiva

Anesiva, Inc. seeks to be a leader in the development and commercialization of novel pharmaceutical products for pain management. The company's core product platform is based on Adlea, a novel small molecule formulation of capsaicin that is currently being evaluated in multiple clinical trials for the management of acute pain following orthopedic surgeries. Adlea has been shown in previous clinical trials to provide extended pain relief after only a single administration in multiple indications for site-specific, acute and chronic, moderate-to-severe pain.

Anesiva is based in South San Francis
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SOURCE Anesiva, Inc.
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Related medicine technology :

1. Anesiva Accelerates Its Transition to Specialty Pharma Pain Management Company
2. Anesiva Commences Phase 2 Trial of Adlea(TM) in Arthroscopic Shoulder Surgery
3. Anesiva Announces South Korea FDA Approval of Adlea(TM) Investigational New Drug Application
4. Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal Pediatrics
5. Anesiva Announces Pivotal Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Total Knee Replacement
6. Anesiva Commences Phase 3 Clinical Trial of Adlea(TM) for Reducing Post-Surgical Pain Following Bunionectomy
7. Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
8. Anesiva Defines Regulatory Pathway for Adlea with FDA
9. Anesiva Initiates Phase 2 Trial with Adlea(TM) for Pain Relief Following Total Hip Replacement Surgery
10. Anesiva Initiates New Phase 2 Trial of Adlea(TM) for Pain Relief Following Knee Replacement Surgery
11. Anesiva Completes Enrollment in Phase 3 Clinical Trial of Zingo(TM) to Treat Pain Associated With Venous Access Procedures in Adults
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