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Acceptance for filing of a sNDA means that the FDA has found the company'ssubmission to be sufficiently complete to review. This review is a standardreview, and under the Prescription Drug User Fee Act (PDUFA), the agency makesa decision regarding marketing clearance of a product candidate within 10months of the date of its submission. The sNDA for Zingo was submitted onMarch 10, 2008.
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"As we approach the commercial launch of Zingo in the pediatric populationin June, FDA's acceptance of our sNDA filing for adults marks anothersignificant step forward for growing the Zingo franchise," said John P.McLaughlin, chief executive officer of Anesiva. "We believe that Zingo canoffer significant relief to adults who experience pain upon peripheral venousaccess procedures, not only in the United States but also worldwide."
Venous access procedures, like IV insertions and blood draws, are amongthe most common procedures performed at a hospital. In 2004, more than 245million adult peripheral venous access procedures and more than 18 millionpediatric peripheral venous access procedures were performed in hospitals inthe United States.(1)
Clinical Data
The sNDA submission is based on results of a multi-center, randomized,double-blind study in 699 adult patients, which demonstrated less proceduralpain associated with blood draws or IV cannulations in those treated withZingo compared to placebo. Of the study participants, 348 patients receivedplacebo and 345 received Zingo one to three minutes before undergoing medicalprocedures requiring venipuncture or IV line placement at the back of hand orantecubital fossa (crux of the elbow). The primary endpoint was pain uponneedle insertion, utilizing the VAS pain scale. The mean pain score in theZingo-treated patients was significantly lower than in the placebo group(p = 0.003).
All three prespecified secondary efficacy endpoints also significantlyfavored Zingo over sham placebo: (1) the proportion of subjects who werepain-free (p < 0.0001); (2) the proportion of responders (p = 0.0005); and (3)the difference between pain experienced during the current (study) venousprocedure 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 ofZingo 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 treatmentdevice again in the future (p = 0.0046).
Demographic characteristics and sites of administration were evenlydistributed across treatment groups. Zingo was found to be well tolerated inthis patient population. The most common skin assessment findings were redness(erythema), red dots (petechiae) and swelling (edema) at the site ofadministration. The incidence of adverse events with Zingo was no higher thanwith placebo.
About Zingo
Zingo is an easy-to-administer, single-use, needle-free system thatdelivers sterile lidocaine powder to provide topical, local analgesia toreduce the pain associated with peripheral IV insertions or blood draws.Zingo's rapid onset of action allows intravenous line placement orvenipuncture to begin one t
