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: (1) the proportion of subjects who were pain-free (p < 0.0001); (2) the proportion of responders (p = 0.0005); and (3) 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).
There was also significantly greater subject satisfaction following use of Zingo compared with sham placebo on additional clinical outcome assessments: (1) satisfaction with overall performance of the device (p = 0.0013); (2) numbing from the device (p < 0.0001); and (3) desire to use the same treatment device again in the future (p = 0.0046).
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.
Zingo is an easy-to-administer, single-use, needle-free system that
delivers sterile lidoca
|SOURCE Anesiva, Inc.|
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