Data from two phase III clinical studies that serve as the foundation for the new drug application demonstrated that Zingo provided statistically significant pain relief in children undergoing venous access procedures such as intravenous 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. In addition to the positive efficacy data from the two trials, treatment with Zingo was found to be safe and well tolerated.
Zingo is a needle-free system that delivers lidocaine powder into the epidermis of the skin and provides analgesia in one to three minutes after administration. This rapid onset, which may be especially useful in pediatric populations and busy emergency room settings, means the product can be incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options.
Anesiva expects to begin a follow-on clinical trial of Zingo in adults in early 2007.