SOUTH SAN FRANCISCO, Calif., March 10 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced that the company has submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) to expand the indication for Zingo to treat the 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.
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).
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.
"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," said John P. McLaughlin, chief executive officer of Anesiva. "Filing the sNDA for Zingo in adults represents another key milestone in Anesiva's efforts to expand and accelerate the growth of Zingo, and potentially offers a solution for adults concerned about pain associated with venous access procedures."
Peripheral venous access procedures are among the most common procedures performed at a hospital, with more than 400 million performed each year in U.S. hospitals on adults. More than 60 million of these procedures take place in the emergency department, and another 27 million IV line placements are associated with pre-surgery procedures.
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.
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 pharmaceutical products for pain management. 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 http://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: the timing and results of our clinical trials, whether Anesiva is able to manufacture its products on commercially reasonable terms, whether Anesiva can secure FDA approval for the use of Zingo in adults, 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 quarterly report on Form 10-Q for the quarter ended September 30, 2007.
Anesiva undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
SOURCE Anesiva, Inc.