Completion of Adult Trial Enrollment follows FDA approval of Zingo in
SOUTH SAN FRANCISCO, Calif., Aug. 28 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) announced today that it has completed enrollment of the Phase 3 clinical study of Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system to reduce pain associated with peripheral venous access procedures in adults. Zingo, a fast-acting topical, needle-free system for local analgesia, was approved by the U.S. Food and Drug Administration (FDA) on August 16, 2007 to reduce the pain associated with venous access procedures, such as IV insertions or blood draws, in children ages three to 18. Anesiva expects to announce results from the adult trial in October.
"Our goal is to utilize the data from this Phase 3 study to file a supplemental new drug application for the use of Zingo in adults," said John P. McLaughlin, chief executive officer of Anesiva. "In addition, we look forward to providing more detail on the commercialization of Zingo in the approved indication for children in the coming weeks."
Venous access procedures, such as IV insertions and blood draws, are among the most common interventions performed in hospitals, with more than 400 million such procedures performed each year in U.S. hospitals.
The Phase 3 study of Zingo in adults enrolled 699 patients undergoing intravenous cannulation or venipuncture procedures at multiple clinical centers in the U.S. Patients were randomized to receive treatment with either Zingo or placebo approximately one to three minutes prior to the peripheral venous access procedure.
Zingo is a ready-to-use, single-use, needle-free system that delivers 0.5 mg sterile lidocaine powder into the skin and provides topical, local analgesia in one to three minutes after administration. This rapid onset, which may be especially useful in pediatric populations and busy emergency room settings, means the product can be incorporated into a medical procedure allowing uninterrupted care, an important advantage over current options. In addition to the hospital setting, Zingo may be used in physicians' offices and clinical laboratories.
About Anesiva and its Diverse Portfolio 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) (formerly 4975), 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.
Forward Looking Statements
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 our products on commercially reasonable terms, whether Anesiva can commercially release new products successfully and the degree to which these products gain 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 June 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.|
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