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:1/22/2015)... , Jan. 22, 2015   Cypher Genomics, ... Sequenom, Inc. (NASDAQ: SQNM ), the ... agreement for next generation noninvasive prenatal tests (NIPT). ... interpretation technology, called Mantis™, to advance analysis of ...
(Date:12/24/2014)... Dec. 24, 2014  United Therapeutics Corporation (NASDAQ: ... MDT ) has submitted a pre-market approval application ... the use of Medtronic,s SynchroMed ® II implantable ... use with United Therapeutics, Remodulin ® (treprostinil) Injection ...
(Date:12/24/2014)... St. Louis, Missouri (PRWEB) December 23, 2014 ... Swiss biotechnology company, Syngenta, are in the process of being ... consolidated case is In Re: Syngenta AG MIR 162 Corn ... the District of Kansas. , Management of the Syngenta GMO ...
(Date:12/24/2014)... December 23, 2014 The report ... its definition, classification, application and industry overview. This ... product cost structure. Production is separated by regions, ... raw materials, equipment, downstream client survey, marketing channels, ...
Breaking Biology Technology:Cypher Genomics and Sequenom Announce Development Agreement 2Cypher Genomics and Sequenom Announce Development Agreement 3Cypher Genomics and Sequenom Announce Development Agreement 4United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 2United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 3United Therapeutics Announces Submission Of Pre-Market Approval Application For Implantable Drug Infusion System To Deliver Remodulin 4Carey Danis & Lowe Reports on Syngenta GMO Corn Transfer Order 2Worldwide Methyl Mercaptan Market 2015-2020 Forecasts on Development & Trends Now Available at ReportsnReports.com 2
... Groton , Connecticut MORRISVILLE, N.C., May ... of APIs, intermediates and Drug Products to the pharmaceutical industry, ... announce the recent award by Pfizer Inc. as the 2008 ... Groton, Connecticut R&D center on May 1, 2009. The award ...
... Blinatumomab in NHL and ALL Highlighted at the ... Combination Data in Breast Cancer to Be Presented ... MeetingBETHESDA, Md., May 20 Micromet, Inc. (Nasdaq: ... novel, proprietary antibodies for the treatment of cancer, ...
... WOODMERE, N.Y., May 19 In an eleventh-hour attempt ... QGLY ) has issued a press release claiming that ... a key staff member of a subsidiary of Quigley, and ... who have offered their own slate of Quigley,s Board of ...
Cached Biology Technology:Pfizer Global R&D Presents 2008 Top Intermediates CMO Award to Asymchem 2Micromet to Present New Clinical Data on Blinatumomab at EHA and on Adecatumumab at ASCO 2Micromet to Present New Clinical Data on Blinatumomab at EHA and on Adecatumumab at ASCO 3Micromet to Present New Clinical Data on Blinatumomab at EHA and on Adecatumumab at ASCO 4Micromet to Present New Clinical Data on Blinatumomab at EHA and on Adecatumumab at ASCO 5In Eleventh-Hour Smear Attempt, Quigley Management Sacrifices Key Employee of its Pharma Division 2In Eleventh-Hour Smear Attempt, Quigley Management Sacrifices Key Employee of its Pharma Division 3
(Date:1/22/2015)... Jan. 13, 2015  Today, FreeWavz ( www.FreeWavz.com ), ... crowdfunding campaign on Fundable, https://www.fundable.com/freewavz . FreeWavz ... production capacity to meet customer demand. ... http://photos.prnewswire.com/prnh/20150113/168790 Invented by ...
(Date:1/22/2015)... 16, 2015  A man-made form of insulin delivered by ... capabilities in adults with mild cognitive impairment and Alzheimer,s ... researchers at Wake Forest Baptist Medical Center. ... mild cognitive impairment (MCI) or mild to moderate Alzheimer,s ...
(Date:1/22/2015)... , Jan. 21, 2015  Analyst Report Issued by Small ... Brands report showed that planet-wide, transactions at merchants on the ... the total number of credit, debit, and prepaid cards reached ... were victims of fraudulent card usage in 2012, and credit ...
Breaking Biology News(10 mins):FreeWavz Launches on Fundable to Drive Speed-to-Market in 2015 2Nasal Spray with Insulin Equivalent Shows Promise as Treatment for Adults with Mild Cognitive Impairment, Alzheimer's Dementia 2Nasal Spray with Insulin Equivalent Shows Promise as Treatment for Adults with Mild Cognitive Impairment, Alzheimer's Dementia 3$4.80 Near Term Price Target with "Buy" given by CapRock Research for NXT-ID, Inc. (NASDAQ: NXTD) issued by Small Cap IR 2
... Epitomics, Inc. announced today that it has signed a ... HealthCare). Epitomics will use its proprietary rabbit monoclonal antibody ... identification and validation. "Epitomics has had ... is a major expansion of our collaboration and confirms ...
... German . Medicines from plants ... that has nothing in common with what the researchers ... Ecology IME in Aachen, Germany, are doing. They use ... many other medications, cannot be chemically produced. Biologically ...
... persist in the often violently competitive realm of bacteria, ... University Bloomington biologists have learned that in one bacterium, ... cheaters and arrest their bids for dominance. ... suppress social cheaters," said Gregory Velicer, who with Ph.D. ...
Cached Biology News:Medicines from plants 2'Policing' stops cheaters from dominating groups of cooperative bacteria 2'Policing' stops cheaters from dominating groups of cooperative bacteria 3'Policing' stops cheaters from dominating groups of cooperative bacteria 4
Rabbit Anti-melatonin (different linkage) Polyclonal Antibody...
Transcription factor Sp2. [Source:Uniprot/SWISSPROT;Acc:Q02086] Antigen: Recombinant Protein Epitope Signature Tag (PrEST)....
Proline-serine-threonine phosphatase-interacting protein 2...
Rabbit Anti-melatonin (different linkage) Polyclonal Antibody...
Biology Products: