SOUTH SAN FRANCISCO, Calif., May 21 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's electronic supplemental New Drug Application (sNDA) filing to expand the indication for Zingo to treat pain associated with peripheral IV insertions and blood draws in adults. Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system is already approved by the FDA to provide local analgesia prior to peripheral IV insertions and blood draws in children three to 18 years of age.
Acceptance for filing of a sNDA means that the FDA has found the company's submission to be sufficiently complete to review. This review is a standard review, and under the Prescription Drug User Fee Act (PDUFA), the agency makes a decision regarding marketing clearance of a product candidate within 10 months of the date of its submission. The sNDA for Zingo was submitted on March 10, 2008.
"As we approach the commercial launch of Zingo in the pediatric population in June, FDA's acceptance of our sNDA filing for adults marks another significant step forward for growing the Zingo franchise," said John P. McLaughlin, chief executive officer of Anesiva. "We believe that Zingo can offer significant relief to adults who experience pain upon peripheral venous access procedures, not only in the United States but also worldwide."
Venous access procedures, like IV insertions and blood draws, are among the most common procedures performed at a hospital. In 2004, more than 245 million adult peripheral venous access procedures and more than 18 million pediatric peripheral venous access procedures were performed in hospitals in the United States.(1)
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 lidocaine powder to provide topical, local analgesia to reduce the pain associated with peripheral IV insertions or blood draws. Zingo's rapid onset of action allows intravenous line placement or venipuncture to begin one to three minutes after administration. In clinical trials, the most common adverse events with Zingo were redness, red dots and swelling. For full Zingo prescribing information, go to http://www.anesiva.com/img/ZingoPackage.pdf
About Anesiva and its Diverse Pipeline of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to be the leader in the development and commercialization of novel therapeutic treatments for pain. The company has one FDA-approved product, Zingo(TM), for the reduction of pain associated with peripheral venous access procedures in children ages three to 18. The second product in Anesiva's pipeline, Adlea(TM), has been shown to reduce pain after only a single administration for weeks to months in multiple settings in numerous mid-stage clinical trials for site-specific, acute and chronic, moderate-to-severe pain. Anesiva is based in South San Francisco, CA. For more information about Anesiva's leadership in the development of products for pain management, and an overview of the clinical challenges being addressed by its product candidates, go to www.anesiva.com.
This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward- looking statements in this press release include matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Zingo gains FDA approval in the adult indication, and the degree to which Zingo gains market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Anesiva's annual report on Form 10-K for the year ended December 31, 2007, and its most recent filing on Form 10-Q.
(1) Data on file at Anesiva, Inc.
Source: Anesiva, Inc.