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Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
Date:10/16/2007

d 345 patients received Zingo one to three minutes before undergoing medical procedures requiring venipuncture or IV line placement at the back of hand or antecubital fossa (crux of the elbow). The primary endpoint was pain upon needle insertion utilizing the VAS pain scale. Demographic characteristics and sites of administration were evenly distributed across treatment groups.

The mean pain score in the Zingo-treated patients was significantly lower than in the placebo group (p = 0.003). Zingo was also well tolerated. The most common skin assessment findings were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration. The incidence of adverse events with Zingo was no higher than with placebo.

About Zingo

Zingo is a ready-to-use, single-use, needle-free system that delivers sterile lidocaine powder into the skin and provides topical, local analgesia in one to three minutes after administration. This rapid onset, which may be especially useful in busy emergency room settings, means the product can be incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options. In addition to the hospital setting, Zingo may be used in physicians' offices and clinical laboratories. Anesiva also intends to expand the product label beyond the pediatric population by filing an sNDA for Zingo in adults in early 2008.

About Anesiva and its Diverse Portfolio of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has one FDA-approved product, Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system, to reduce pain associated with peripheral venous access procedures in children three to 18 years of age. The second product in Anesiva's pipeline, Adlea(TM) (formerly 4975), has been shown to reduce pain after only a
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SOURCE Anesiva, Inc.
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