Navigation Links
FDA Accepts Zingo(TM) Supplemental New Drug Application to Reduce Pain Associated With Peripheral Needle Insertion Procedures in Adults
Date:5/21/2008

>

Clinical Data

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).

All three prespecified secondary efficacy endpoints also significantly favored Zingo over sham placebo: (1) the proportion of subjects who were pain-free (p < 0.0001); (2) the proportion of responders (p = 0.0005); and (3) the difference between pain experienced during the current (study) venous procedure compared with the recollection of pain experienced during a prior (historical) venous procedure (p = 0.0002).

There was also significantly greater subject satisfaction following use of Zingo compared with sham placebo on additional clinical outcome assessments: (1) satisfaction with overall performance of the device (p = 0.0013); (2) numbing from the device (p < 0.0001); and (3) desire to use the same treatment device again in the future (p = 0.0046).

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.

About Zingo

Zingo is an easy-to-administer, single-use, needle-free system that delivers sterile lidoca
'/>"/>

SOURCE Anesiva, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. FDA Accepts ISO-Vorin(TM) New Drug Application Amendment Submitted by Spectrum Pharmaceuticals
2. FDA Accepts Sucampos sNDA for Lubiprostone (8 mcg) for the Treatment of Irritable Bowel Syndrome with Constipation (IBS-C)
3. FDA Accepts Ranexa(R) sNDA and NDA for Filing
4. EMEA Accepts for Review Vidaza(R) Marketing Authorization Application for Higher-Risk Myelodysplastic Syndromes
5. Imaging Diagnostic Systems Accepts Resignations of Outside Directors
6. U.S. Government Accepts $192 Million of sanofi pasteur H5N1 Bulk Vaccine Antigen for Pandemic Stockpile
7. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
8. Anesiva to Host Conference Call and Webcast Tomorrow to Discuss Encouraging Development in Zingo(TM) Program
9. Anesiva Signs Co-Promotion and Distribution Agreement With Sagent Pharmaceuticals for Zingo(TM) in U.S. Hospitals
10. Anesiva Outlines Comprehensive Commercialization Plan for FDA Approved Product Zingo(TM)
11. Anesiva Announces Submission of Supplemental New Drug Application for Zingo(TM) to Reduce Pain Associated With Needle Insertion Procedures in Adults
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/27/2014)... The Europe Thermal Protective Clothing market report defines ... forecasts. It estimates the market to reach $577.9 ... 7.5%, from 2013 to 2018. , Browse through ... market report for a glimpse of the market ... and figures. , http://www.micromarketmonitor.com/market/europe-thermal-protective-clothing-5957050557.html , Protective ...
(Date:11/27/2014)... 27, 2014 First articles ... Elsevier , a world-leading provider of ... pleased to announce the launch of a new journal: ... The launch of Extreme Mechanics Letters ... the forefront of applied sciences such as micro and ...
(Date:11/26/2014)... 2014 (PRWEB) November 26, 2014 Publicis ... network, today announced the organization has won a total ... Awards. Digitas Health LifeBrands was honored with a Silver ... PHCG agencies received eight Awards of Excellence. , ... of pharmaceutical advertising and promotion. The Awards provide a ...
(Date:11/26/2014)... The North America Thermal Protective Clothing Market ... analysis of the growth trends and revenue forecasts. ... by 2018, growing at a CAGR of 7.1% ... TOC of the North America Thermal Protective Clothing ... in-depth analysis and industry segmentation supported by various ...
Breaking Biology Technology:The Europe Thermal Protective Clothing market is estimated to grow up to $577.9 million by 2018 - Report by MicroMarket Monitor 2The Europe Thermal Protective Clothing market is estimated to grow up to $577.9 million by 2018 - Report by MicroMarket Monitor 3Elsevier Announces the Launch of a New Journal: Extreme Mechanics Letters 2Elsevier Announces the Launch of a New Journal: Extreme Mechanics Letters 3Publicis Healthcare Wins 20 Rx Club Awards 2Publicis Healthcare Wins 20 Rx Club Awards 3The North America Thermal Protective Clothing Market is estimated to grow up to $616.3 million by 2018 - Report by MicroMarket Monitor 2The North America Thermal Protective Clothing Market is estimated to grow up to $616.3 million by 2018 - Report by MicroMarket Monitor 3
... SAN MATEO, Calif., July 31 NeurogesX, Inc. (Nasdaq: ... commercializing novel pain management therapies, today announced it will hold a ... (6:00 a.m. PT) to report results for its second quarter 2009. ... hosted by Anthony DiTonno, President and Chief Executive Officer, and Stephen ...
... ANNAPOLIS, Md., July 31 PharmAthene, Inc. (NYSE Amex: ... biological and chemical threats, today announced that, effective July 28, ... unsecured senior convertible notes ("Notes") and common stock purchase warrants ... , In connection with the private placement, ...
... SHANGHAI, July 31 /PRNewswire-Asia-FirstCall/ -- ... Company"), a leading Chinese firm,specializing in the manufacture, ... announced it has submitted,applications for four patents to ... of China. , These ...
Cached Biology Technology:NeurogesX to Hold Conference Call to Discuss Second Quarter 2009 Financial Results 2NeurogesX to Hold Conference Call to Discuss Second Quarter 2009 Financial Results 3PharmAthene, Inc. Closes on $19.3 Million Private Placement of Convertible Notes and Common Stock Warrants 2PharmAthene, Inc. Closes on $19.3 Million Private Placement of Convertible Notes and Common Stock Warrants 3PharmAthene, Inc. Closes on $19.3 Million Private Placement of Convertible Notes and Common Stock Warrants 4China-Biotics, Inc. Applies for Four Patents on Probiotic Formulations 2China-Biotics, Inc. Applies for Four Patents on Probiotic Formulations 3
(Date:11/6/2014)... - Insilico Medicine, Inc, a Baltimore-based bioinformatics company ... diseases announced a research collaboration with the international ... Inc (OTC: CSBR). , "There are many companies ... Champions Oncology,s TumorGraft technology is unique in a ... experimentally generating vast amounts of valuable data. Our ...
(Date:11/5/2014)... career to understanding the Earth,s climate and communicating ... deputy director and regional climatologist for the Western ... Redmond has more than three decades of experience ... data to the general public. , At its ... December 15-19, 2014 the American Geophysical Union (AGU) ...
(Date:11/4/2014)... 5, 2014 – University of Utah engineers developed the ... jet fuel produce electricity without needing to ignite the ... power portable electronics, off-grid power and sensors. , A ... the American Chemical Society journal ACS Catalysis . ... chemical reaction between a fuel and an oxygen-rich source ...
Breaking Biology News(10 mins):Insilico Medicine, Inc announces research collaboration with Champions Oncology, Inc 2Nevada climatologist to be honored at AGU Fall Meeting for lifetime of public outreach 2Jet-fueled electricity at room temperature 2
... Discoveries about tropical coral reefs, to be published on 23 ... restore the corals, which are succumbing to bleaching and other ... The research gives new insights into how the scientists ... protect coastlines, foster tourism, and nurture many species of fish. ...
... HOUSTON, June 24, 2010 Many diseases of brain function, ... how neurons communicate with each other. A University of ... and connections in an attempt to prevent those diseases. ... UH,s biology and biochemistry department, describes his team,s findings in ...
... perennial grain crops, which grow with less fertilizer, herbicide, ... available in two decades, according to researchers writing in ... Perennial grains would be one of the largest ... could arrive even sooner with the right breeding programs, ...
Cached Biology News:Discovery of how coral reefs adapt to global warming could aid reef restoration 2Discovery of how coral reefs adapt to global warming could aid reef restoration 3Discovery of how coral reefs adapt to global warming could aid reef restoration 4Researchers at UH work to prevent neurological diseases 2Agriculture's next revolution -- perennial grain -- within sight 2
... scales with RS232 ports and sends that data ... type the weight into the program, BalanceTalk can ... use parser extracts required data , Add date/time ... Collect data at timed intervals , Keyboard macros ...
...
Mitochondria/Cytosol Fractionation Kit Research Focus: other Storage Temperature: 4C Shipping Temperature: 4C...
Mouse monoclonal [5H9] to RAD52 ( Abpromise for all tested applications). entrezGeneID: 5893 SwissProtID: P43351...
Biology Products: