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news.Anesiva has announced that the FDA has accepted the company's electronic supplemental new drug application filing to expand the indication for Zingo to treat 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. 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).
All three prespecified secondary efficacy endpoints also significantly favored Zingo over sham placebo – the proportion of subjects who were pain-free (p < 0.0001); the proportion of responders (p = 0.0005); and the difference between pain experienced during the current (study) venous procedure compared with the recollection of pain experienced during a prior (historical) venous procedure (p = 0.0002). John McLaughlin, CEO of Anesiva, said: "We believe that Zingo can offer significant relief to adults who experience pain upon peripheral venous access procedures, not only in the US but also worldwide."