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news.Anesiva has submitted a supplemental new drug application or sNDA with the FDA to expand the indication for Zingo, to treat the pain associated with peripheral IV insertions and blood draws in adults.
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The sNDA submission is based on results of a multi-center, randomized, 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. Demographic characteristics and sites of administration were evenly distributed across treatment groups. Zingo was found to be well tolerated in this patient population.
John McLaughlin, CEO of Anesiva, said: “The initial commercial thrust for Zingo is in the pediatric 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.”