Anesiva submits sNDA to US FDA to expand indication for Zingo

Anesiva, Inc. has submitted a supplemental New Drug Application (sNDA) with the US Food and Drug Administration (FDA) to expand the indication for Zingo to treat the pain associated with peripheral IV insertions and blood draws in adults. Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system is already approved by the FDA to provide local analgesia prior to peripheral IV insertions and blood draws in children three to 18 years of age.

The sNDA submission is based on results of a multi-centre, randomised, double-blind study in 699 adult patients, which demonstrated less procedural pain associated with blood draws or IV cannulations in those treated with Zingo compared to placebo. Of the study participants, 348 patients received placebo and 345 received Zingo one to three minutes before undergoing medical procedures requiring venipuncture or IV line placement at the back of hand or antecubital fossa (crux of the elbow). The primary endpoint was pain upon needle insertion, utilizing the VAS pain scale. The mean pain score in the Zingo-treated patients was significantly lower than in the placebo group (p = 0.003).

Demographic characteristics and sites of administration were evenly distributed across treatment groups. Zingo was found to be well tolerated in this patient population. The most common skin assessment findings were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration. The incidence of adverse events with Zingo was no higher than with placebo.

"The initial commercial thrust for Zingo is in the paediatric setting, where we have focused our marketing efforts and have an experienced sales force already in place in advance of the planned commercial availability of Zingo in the second quarter of 2008," said John P. McLaughlin, chief executive officer, Anesiva. "Filing the sNDA for Zingo in adults represents another key milestone in Anesiva's efforts to expand and accelerate the growth of Zingo, and potentially offers a solution for adults concerned about pain associated with venous access procedures."

Peripheral venous access procedures are among the most common procedures performed at a hospital, with more than 400 million performed each year in US hospitals on adults. More than 60 million of these procedures take place in the emergency department, and another 27 million IV line placements are associated with pre-surgery procedures.

Zingo is an easy-to-administer, single-use, needle-free system that delivers sterile lidocaine powder to provide topical, local analgesia to reduce the pain associated with peripheral IV insertions or blood draws. Zingo's rapid onset of action allows intravenous line placement or venipuncture to begin one to three minutes after administration. In clinical trials, the most common adverse events with Zingo were redness, red dots and swelling.