August 17, 2007 — Anesiva Inc. announced today that the FDA has approved Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws, in children ages three to 18.
Zingo is an easy-to-administer, single-use, needle-free system containing 0.5 mg sterile lidocaine powder. It provides a rapid onset of action, allowing intravenous line placement or venipuncture to begin one to three minutes after administration.
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.
Data from two pivotal, placebo-controlled, Phase 3 clinical studies, 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 that involves a needlestick procedure, and more than half of all children -- even those older than seven -- cry during these procedures. The problem is compounded in children with chronic illnesses who must undergo frequent IV insertions.
For more information: www.anesiva.com