Anesiva Receives FDA Approval for Zingo, a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
SOUTH SAN FRANCISCO, Calif., Aug. 17 /PRNewswire-FirstCall/ -- Anesiva, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Zingo (lidocaine hydrochloride monohydrate) powder intradermal injection system, which provides rapid, topical, local analgesia to reduce the pain associated with venous access procedures, such as IV insertions or blood draws, in children ages three to 18. Zingo is an easy-to-administer, single-use, needle-free system containing 0.5 mg sterile lidocaine powder. It provides a rapid onset of action, allowing intravenous line placement or venipuncture to begin one to three minutes after administration.
"Blood draws and IV insertions are the most frequently reported painful events in hospitalized children. Despite guidelines recommending the use of topical anesthetics prior to venous access procedures, currently available local anesthetics commonly take 20 minutes or longer to act, making their use in today's fast-paced hospital environment difficult. FDA approval of Zingo provides a unique option for healthcare providers who strive to safely and effectively manage children's pain during these procedures," said John P. McLaughlin, chief executive officer of Anesiva. "Anesiva is committed to improving pain management, and the approval of Zingo marks an important step toward reaching this goal. This favorable decision by the FDA to approve Zingo came more than five weeks earlier than our PDUFA date of September 24th, and we are grateful for the efforts put in by the agency and for the cooperative relationship that we enjoyed during this process."
Guidelines and recommendations from the American Academy of Pediatrics, the American Pain Society and the Infusion Nurses Society all call for the use of topical anesthetics prior to venous access procedures.
"Healthcare providers have always faced an uncomfortable trade-off when it comes to the use of topical anesthetics: they can choose speed and convenience or patient comfort," said William T. Zempsky, M.D., associate professor, Department of Pediatrics, University of Connecticut; associate director, Pain Relief Program, Connecticut Children's Medical Center, Hartford, who led the pediatric clinical trials of Zingo. "With Zingo, doctors and nurses can offer the best of both worlds, providing pain control that won't slow the delivery of medical care."
Data from two pivotal, placebo-controlled, Phase 3 clinical studies, which collectively enrolled 1,109 patients across 15 U.S. clinical centers, demonstrated that Zingo, a preparation of powdered lidocaine administered through a needle-free, pre-filled, disposable device, provided statistically significant pain relief in children ages three to 18 undergoing venous access procedures, such as IV line placements. These data indicated that treatment with Zingo quickly and effectively reduced pain when given just one to three minutes prior to the venous access procedure. Zingo was well-tolerated. The most common adverse reactions were redness (erythema), red dots (petechiae) and swelling (edema) at the site of administration.
Venous access procedures, like IV insertions and blood draws, are among the most common interventions performed at a hospital, with more than 18 million pediatric venous access procedures and 400 million total procedures per year in the U.S. Needlesticks are also a source of deep anxiety. An Impulse Research survey conducted last year by Anesiva found that 70 percent of children experience fear and stress during a visit to the doctor or hospital that involves a needlestick procedure, and more than half of all children -- even those older than seven -- cry during these procedures. The problem is compounded in children with chronic illnesses who must undergo frequent IV insertions.
"Pre-treating pain associated with venous access procedures is the right thing to do, and parents should feel comfortable asking how pain can be minimized for their child," said Micke A. Brown, BSN, RN, director of advocacy, American Pain Foundation. "Regular use of topical anesthetics to lessen a painful needlestick can be a nurse's best friend. It allows us to quickly gain patient trust and sets a therapeutic tone that positively affects the hospital experience."
Anesiva will provide updated information on the commercialization plan for Zingo in the coming weeks. In addition, Anesiva is now studying Zingo in a large Phase 3 trial in adults. The company will use the data generated in that trial as the basis for an FDA filing to expand the label to include adults.
There may be opportunities to use the needle-free delivery technology employed in Zingo for the delivery of drugs other than lidocaine. Possible drug candidates include insulin, human growth hormone, erythropoietin, calcitonin, and other medications, excluding vaccines. The company may license the rights to the use of this technology for such other medications to third parties.
Zingo is a ready-to-use, single-use, needle-free system that delivers sterile lidocaine powder into the epidermis of 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.
Conference Call Details
Anesiva will conduct a webcast conference call with the investment community at 8:30 a.m. ET, today, August 17, 2007, 2007 to discuss this announcement. Interested parties can listen to the live audio webcast by dialing (800) 340-6289 (international dial: (706) 634-1538) or by logging on to http://www.anesiva.com and going to the Investor Information page. For those unable to participate via the Internet, a 24-hour replay will be available for seven days after the call by (800) 642-1687 (international dial: (706) 645-9291) and giving the following pass code: 13882358.
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, 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 (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, 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.
CONTACT: Paul Goodson, Sr. Dir. of Investor Relations, +1-650-246-6898, orJennifer Cook Williams, VP of Investor Relations, +1-650-624-9600,, all of Anesiva; or, media, Carolyn Bumgardner Wangof WeissComm Partners, +1-415-225-5050, , forAnesiva, Inc. firstname.lastname@example.org email@example.com
Web site: http://www.anesiva.com/
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Posted: August 2007
- Anesiva Announces FDA Approval of sNDA to Expand Zingo Indication to Include Adults - January 9, 2009
- Endo Comments on Notices Received From Anesiva Regarding Zingo - April 10, 2007
- Anesiva Announces FDA Acceptance for Filing of Zingo New Drug Application to Reduce Pain Associated With Needle Insertion Procedures in Children - February 7, 2007
- Anesiva Announces Filing of New Drug Application for Zingo to Reduce Pain Associated with Needle Insertion Procedures in Children - November 27, 2006