Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal ... (nful events in hospitalized children.(3)...)

Anesiva Announces Publication of Phase 3 Zingo(TM) Data in the Journal Pediatrics

Date:5/5/2008

nful 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 rat
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