Anesiva begins recruitment in phase III trial

Patients enrolled in the trial will receive treatment with either Zingo or placebo approximately one to three minutes prior to the peripheral venous access procedure. Anesiva said it anticipated data from this phase III trial later this year.

Anesiva has requested marketing clearance form the FDA for Zingo to treat pain associated with intravenous cannulation and venipuncture procedures in children.

Data from two previously completed phase III clinical studies served as the foundation for the application for approval and demonstrated that Zingo provided pain relief in children undergoing peripheral venous access procedures, such as intravenous line placements.

These studies, which met the pre-specified primary endpoint, also showed that Zingo provided pain reduction when given one to three minutes prior to the peripheral venous access procedure.

According to Anesiva, this rapid onset may be especially useful in busy emergency room settings and means the product can be incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options.