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Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal Pediatrics
Date:5/5/2008

- Zingo Demonstrates Quick, Effective Analgesia for Peripheral Venous

Access Procedures in Children Three to 18 Years of Age -(1)

SOUTH SAN FRANCISCO, Calif., May 5 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) announced today the publication of data in Pediatrics, the journal of the American Academy of Pediatrics, from a Phase 3 trial of Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection, the company's fast-acting, topical, needle-free local anesthetic, that showed treatment with Zingo was associated with significantly less pain during intravenous (IV) line placement or venipuncture as compared to sham placebo.(1) The study is the largest trial published to date on local anesthetic use for peripheral venous access procedures in children.

"Increased use of topical local anesthetics has long been urged to reduce peripheral venous access pain in children, but use of those tools has been limited by slow onset of action," said William T. Zempsky, M.D., Associate Professor, Department of Pediatrics, University of Connecticut; Associate Director, Pain Relief Program, Connecticut Children's Medical Center, Hartford, who led the pediatric clinical trials of Zingo. "As demonstrated in the Phase 3 trial, Zingo's rapid action is a leap forward in the control of peripheral venous access pain management for children."

More than 18 million children undergo venous access procedures, including blood draws and IV insertions, in U.S. hospitals each year.(2) In addition to the commonality of venous access procedures, they are also a source of pain for children.(3) According to a study published in the journal Pediatric Nursing, IV insertions and blood draws are the most frequently reported painful events in hospitalized children.(3) Another study shows that more than a third of children (36%) report having moderate to severe pain during blood draws.(4)

This Phase 3 study, called COMFORT-003 (Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-free Powder Lidocaine or Placebo Treatment), demonstrated Zingo's rapid onset of action, allowing peripheral venous access procedures, such as IV insertions or blood draws, to begin one to three minutes after administration.(1) Guidelines from the American Academy of Pediatrics, the American Pain Society and the Infusion Nurses Society have all recommended use of topical anesthetics prior to venous access procedures(5), but since many currently available local anesthetics take 20 minutes or longer to become effective, they're often difficult to use in a fast-paced hospital environment. According to a national survey of Pediatric Emergency Department Fellowship Directors, current topical anesthetics are used for only 38 percent of IV placements in children.(6)

The study was a randomized, double-blind, placebo-controlled, single-dose, Phase 3 study to assess efficacy and safety. It compared 292 patients from age three to 18 who received Zingo with a group of 287 patients who were treated with a sham placebo device that did not administer medication.(1)

Zingo demonstrated a statistically significant reduction in pain by all measures studied.
-- Patients receiving Zingo reported less pain (1.77) compared to

patients in the control group (2.10) by children's self report using

the Wong-Baker Faces scale (p=0.011).

-- A secondary measure of pain, the visual analog scale (VAS), was also

used in patients eight to 18 years old, and patients who received

Zingo also reported significantly lower VAS scores (22.62) compared to

sham placebo (31.97) (p<0.001).

-- Parents of patients who received Zingo also rated their child's pain

as significantly lower than parents of children receiving the sham

placebo device (p<0.001).(1)

Zingo was found to be well tolerated in this patient population, with no serious drug-related adverse events reported. 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 sham placebo.(1) Demographic characteristics and sites of administration were evenly distributed across treatment groups.

The U.S. Food and Drug Administration (FDA) approved Zingo last year for children three to 18 years of age based on the results of the COMFORT-003 study and a second large clinical trial, COMFORT-004, which also found that use of Zingo was related to significantly less peripheral venous access procedural pain in children.

About Zingo and Venous Access Procedures

Zingo is a needle-free system that delivers lidocaine powder into the skin and provides analgesia in one to three minutes after administration.

In clinical trials, Zingo was well-tolerated. The most common adverse reactions in clinical trials were erythema, petechiae, and edema at the site of administration.(7) Full prescribing information is available at http://www.anesiva.com/img/ZingoPackage.pdf.

In addition to the hospital population, opportunities exist for Zingo in children in hemodialysis centers, as well as physicians' offices and clinical laboratories. In March, Anesiva submitted a supplemental New Drug Application with the U.S. Food and Drug Administration to expand the indication for Zingo to treat the pain associated with peripheral IV insertions and blood draws in adults.

About Anesiva and its Diverse Pipeline of Pain Products

Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel pharmaceutical products for pain management. The company has one FDA-approved product, Zingo(TM) for the reduction of pain associated with venous access procedures. The second product in the pipeline, Adlea, has been shown to reduce pain after only a single administration for weeks to months in multiple settings based on mid-stage clinical trials for site-specific, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to http://www.anesiva.com.

(1) Zempsky WT, Bean-Lijewski J, Kauffman RE et al. Needlefree Powder

Lidocaine Delivery System Provides Rapid Effective Analgesia for

Venipuncture or Cannulation Pain in Children: Randomized,

Double-Blind Comparison of Venipuncture and Venous Cannulation Pain

After Fast-Onset Needlefree Powder Lidocaine or Placebo Treatment

Trial. Pediatrics. 2008;121(5):1-9.

(2) Anesiva, Data on File.

(3) Wong DL and Baker CM. Pain in Children: Comparison of Assessment

Scales. Pediatric Nursing. 1988;14:9-17.

(4) Fradet C, McGrath PJ, Kay J, Adams S, Luke B. A prospective survey

of reactions to blood tests by children and adolescents. Pain.

1990;40:53-60.

(5) American Academy of Pediatrics Committee on Psychosocial Aspects of

Child and Family Health and American Pain Society Task Force on Pain

in Infants, Children, and Adolescents. The assessment and management

of acute pain in infants, children, and adolescents. Pediatrics.

2001;108:793-797.

(6) Bhargava R, Young K. Procedural pain management patterns in academic

pediatric emergency departments. Academic Emergency Medicine.

2007;14:479-482.

(7) Zingo(TM) Full Prescribing Information.


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SOURCE Anesiva, Inc.
Copyright©2008 PR Newswire.
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