SOUTH SAN FRANCISCO, Calif., Aug. 28 Anesiva,Inc. (Nasdaq: ANSV) announced today that it has completed enrollment of thePhase 3 clinical study of Zingo(TM) (lidocaine hydrochloride monohydrate)powder intradermal injection system to reduce pain associated with peripheralvenous access procedures in adults. Zingo, a fast-acting topical, needle-freesystem for local analgesia, was approved by the U.S. Food and DrugAdministration (FDA) on August 16, 2007 to reduce the pain associated withvenous access procedures, such as IV insertions or blood draws, in childrenages three to 18. Anesiva expects to announce results from the adult trial inOctober.
"Our goal is to utilize the data from this Phase 3 study to file asupplemental new drug application for the use of Zingo in adults," said JohnP. McLaughlin, chief executive officer of Anesiva. "In addition, we lookforward to providing more detail on the commercialization of Zingo in theapproved indication for children in the coming weeks."
Venous access procedures, such as IV insertions and blood draws, are amongthe most common interventions performed in hospitals, with more than 400million such procedures performed each year in U.S. hospitals.
The Phase 3 study of Zingo in adults enrolled 699 patients undergoingintravenous cannulation or venipuncture procedures at multiple clinicalcenters in the U.S. Patients were randomized to receive treatment with eitherZingo or placebo approximately one to three minutes prior to the peripheralvenous access procedure.
Zingo is a ready-to-use, single-use, needle-free system that delivers 0.5mg sterile lidocaine powder into the skin and provides topical, localanalgesia in one to three minutes after administration. This rapid onset,which may be especially useful in pediatric populations and busy emergencyroom settings, means the product can be incorporated into a medical procedureallowing uninterrupted care, an important advantage over current options. Inaddition to the hospital setting, Zingo may be used in physicians' offices andclinical laboratories.
About Anesiva and its Diverse Portfolio of Pain Products
Anesiva, Inc. is a late-stage biopharmaceutical company that seeks to bethe leader in the development and commercialization of novel therapeutictreatments for pain. The company has one FDA-approved product, Zingo(TM), forthe reduction of pain associated with peripheral venous access procedures inchildren ages three to 18. The second product in Anesiva's pipeline, Adlea(TM)(formerly 4975), has been shown to reduce pain after only a singleadministration for weeks to months in multiple settings in numerous mid-stageclinical trials for site-specific, acute and chronic, moderate-to-severe pain.Anesiva is based in South San Francisco, CA. For more information aboutAnesiva's leadership in the development of products for pain management, andan overview of the clinical challenges being addressed by its productcandidates, go to http://www.anesiva.com.
Forward Looking Statements
This press release includes "forward-looking statements" within themeaning of the safe harbor provisions of the United States Private SecuritiesLitigation Reform Act of 1995. Words such as "expect," "estimate," "project,""budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could,""should," "believes," "predicts," "potential," "continue," and similarexpressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include matters that involve knownand unknown risks, uncertainties and other factors that may cause actualresults, levels of activity, performance or achievements to differ materiallyfrom results expressed or implied by this press release. Such risk factorsinclude, among others: the timing and results of our clinical trials, whetherAnesiva is able to manufa