Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures i... (e enjoyed during this process. Guide...)

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Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children

Date:8/19/2007

e enjoyed during this process."

Guidelines and recommendations from the American Academy of Pediatrics, the American Pain Society and the Infusion Nurses Society all call for the use of topical anesthetics prior to venous access procedures.

"Healthcare providers have always faced an uncomfortable trade-off when it comes to the use of topical anesthetics: they can choose speed and convenience or patient comfort," 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. "With Zingo, doctors and nurses can offer the best of both worlds, providing pain control that won't slow the delivery of medical care."

Data from two pivotal, placebo-controlled, Phase 3 clinical studies, which collectively enrolled 1,109 patients across 15 U.S. clinical centers, demonstrated that Zingo, a preparation of powdered lidocaine administered through a needle-free, pre-filled, disposable device, provided statistically significant pain relief in children ages three to 18 undergoing venous access procedures, such as IV line placements. These data indicated that treatment with Zingo quickly and effectively reduced pain when given just one to three minutes prior to the venous access procedure. Zingo was well-tolerated. The most common adverse reactions were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration.

Venous access procedures, like IV insertions and blood draws, are among the most common interventions performed at a hospital, with more than 18 million pediatric venous access procedures and 400 million total procedures per year in the U.S. Needlesticks are also a source of deep anxiety. An Impulse Research survey conducted last year by Anesiva found that 70 percent of children experience fear and stress during a visit to the doctor or hospital
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SOURCE Anesiva, Inc.

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Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures i...(e enjoyed during this process. Guide...)