Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal ...(ed their child's pain as signific...),Health
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ed 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
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| SOURCE Anesiva, Inc. Copyright©2008 PR Newswire. All rights reserved |
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