Zingo™ Clinical Data

Pediatric Data

The efficacy of Zingo™ (lidocaine hydrochloride monohydrate) powder intradermal injection system in patients 3–18 years of age was evaluated in 2 randomized, double-blind, parallel-arm, sham-placebo controlled trials in which pediatric patients received either Zingo or a sham placebo device. The overall patient population consisted of healthy pediatric patients as well as those with acute and chronic medical conditions (i.e., diabetes, asthma, seizure disorder, juvenile rheumatoid arthritis and renal or hepatic transplantation). All patients required peripheral venipuncture or intravenous cannulation as part of their clinical care.

Two efficacy trials (COMFORT* 3 and COMFORT* 4) were conducted during which patients were treated with Zingo or a placebo device at the back of hand or antecubital fossa (crook of the elbow), between one and three minutes prior to venipuncture or peripheral venous cannulation. Measurements of pain were made immediately following the venous procedure. Efficacy was measured using a modified version of the Wong-Baker FACES pain rating scale [a categorical six-point scale containing six faces ranging from 0 (“no hurt”) to 5 (“hurts worst”)]. In both studies, treatment with active drug resulted in less pain, from venipuncture or peripheral IV cannulation, compared with placebo. The most common adverse reactions were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration.

1. Least Squares Mean; 2. Standard Error; 3. Confidence Interval; 4. Data on file
*COMparison of Venipuncture and Venous Cannulation Pain After Fast Onset Needlefree PowdeR Lidocaine or Placebo Treatment

Adult Data

Results of a randomized, double-blind placebo-controlled Phase 3 clinical trial, enrolling nearly 700 adult patients, demonstrated that patients undergoing peripheral venipuncture or IV cannulation after Zingo treatment experienced significantly less pain versus placebo (p =0.003). The incidence of adverse events was similar to those observed in the pediatric trials, and included redness, red dots and swelling at the site of administration. Anesiva has submitted a supplemental new drug application (sNDA) for the adult Zingo indication and anticipates FDA action by January 2009.

For more information on Zingo, visit www.Zingo.com, call 866-ZINGORX (866-946-4679), or send an e-mail to medinfo@anesiva.com