Anesiva Begins Study of Fast-Acting Local Anesthetic

Anesiva has begun enrolling adult patients in a Phase III clinical study of Zingo, the company's fast-acting local anesthetic to treat pain associated with peripheral venous access procedures.

The trial is designed to enroll 700 adults undergoing intravenous cannulation or venipuncture procedures at multiple clinical centers in the U.S. Patients enrolled in the trial will be randomized to receive treatment with either Zingo or placebo approximately one to three minutes prior to the peripheral venous access procedure. Anesiva has submitted a new drug application (NDA) to the FDA requesting approval of 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 of the NDA and demonstrated that Zingo provided pain relief in children undergoing peripheral venous access procedures, such as intravenous line placements. These studies, which met prespecified primary endpoints, also showed that Zingo provided pain reduction when given one to three minutes prior to the peripheral venous access procedure.

These two studies collectively enrolled 1,109 patients at 15 clinical centers. Zingo was shown to be well tolerated in these studies, but the frequency and severity of skin-site abnormalities were greater in the Zingo group, particularly relating to redness of the skin. However, most skin reactions were minor, short-lived and self-limited, the company said. Zingo also met the primary endpoint and was found to be well tolerated in several early-stage clinical trials in adults.

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 may be especially useful in busy emergency-room settings, the company said.