Navigation Links
Anesiva Completes Enrollment in Phase 3 Clinical Trial of Zingo(TM) to Treat Pain Associated With Venous Access Procedures in Adults
Date:8/28/2007

Completion of Adult Trial Enrollment follows FDA approval of Zingo in

Children

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.

About Zingo

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.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Anesiva Announces Phase 2 Data Showing Substantial, Long-Term Pain Reductions with Adlea(TM) (formerly 4975) in Osteoarthritis of the Knee
2. Lev Pharmaceuticals Completes Phase III Prophylaxis Trial of C1-Esterase Inhibitor for Hereditary Angioedema
3. Celsion Completes Enrollment in Phase I Liver Cancer Study
4. LANI completes Phase I in Japan and to commence Phase I in UK
5. Ace Biosciences, Ace393, the Worlds First Commercial Vaccine for Travellers Diarrhoea Caused by Campylobacter Successfully Completes Phase I Clinical Trials
6. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
7. NexMed Announces Completion of Patient Enrollment in Two Pivotal Phase 3 Studies for Anti-Fungal Product
8. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
9. Phase 3 Results for Dabigatran Etexilate, an Investigational Oral Anticoagulant, Presented Today at the XXIst Congress of the International Society on Thrombosis and Haemostasis
10. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
11. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2016)... 2016  Compass Diversified Holdings (NYSE: CODI ... of leading middle market businesses, announced today its consolidated ... 2016. First Quarter 2016 Highlights , ... or "Cash Flow") of $13.6 million for the first ... $15.0 million for the first quarter of 2016; ...
(Date:5/4/2016)... COUNTY, Calif. , May 4, 2016  It,s time for an upgrade. There ... shown on a brilliant 3.5 inch LCD, the illustrious DVMAXX HD  offers unparalleled ... brands as well as a world class manufacturer of innovative technology.  Photo ... ... ...
(Date:5/4/2016)... YORK , May 4, 2016 ... Share, Development, Growth and Demand Forecast to 2022 - Industry ... User (Hospital, Diagnostic Center and Others)" by P&S Market Research, ... $4,894.3 million in 2015, and it is expected to grow ... type, the high slice type segment is expected to witness ...
Breaking Medicine Technology:
(Date:5/4/2016)... ... May 04, 2016 , ... Connor Sport Court ... for the 2016 NCAA Men’s National Collegiate Volleyball Championship. , Sport ... championship to be held May 5-7 at Pennsylvania State University’s Rec Hall in ...
(Date:5/4/2016)... ... May 04, 2016 , ... ... families of Camas and Vancouver, WA, has announced the latest beneficiary of ... Breast Cancer Foundation and their Mammography Program, which provides free mammograms and ...
(Date:5/4/2016)... ... May 04, 2016 , ... Level 10 Head Over Heels Athletic ... to the University of Arizona for the fall of 2019. , After a ... Brovedani’s commitment to the GymCats came from her connection with the coaching staff and ...
(Date:5/4/2016)... MA (PRWEB) , ... May 04, 2016 , ... ... help fund Dr. Todd Rider's research and development of DRACO broad-spectrum antiviral therapeutics. ... In the campaign that starts on May 3, 2016 at http://igg.me/at/EndTheVirus ...
(Date:5/4/2016)... ... May 04, 2016 , ... Olshan ... commercial real estate proudly announced that its service-based charitable program, Olshan Outreach, successfully ... portfolio-wide will continue Olshan Properties’ annual philanthropic tradition in 2016 with the ‘Fight ...
Breaking Medicine News(10 mins):