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Anesiva’s Phase III trial of Zingo meets primary endpoint

Biopharmaceutical company Anesiva has announced positive top-line results from its pivotal multi-center, randomized, double-blind Phase III study with 699 adult patients.

The study met its primary endpoint, demonstrating less venous procedural pain in those treated with Zingo powder intradermal injection system compared to placebo.

Patients received zingo or placebo (p= 0.003) one to three minutes prior to undergoing venous access procedures (intravenous insertions or blood draws). 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.

John McLaughlin, CEO of Anesiva, said: “We’ve now shown that zingo works in both the pediatric and adult populations. An expanded label from the Food and Drug Administration to include adults could greatly expand the market opportunity for us. We have a world-class commercialization team that has significant efforts underway to prime the market for zingo’s introduction to pediatric hospitals in order to prepare for a strong launch and the development of a very successful business.”