Navigation Links
Anesiva Announces Pivotal Phase 3 Trial of Zingo(TM) Meets Primary Endpoint and Significantly Reduces Venous Access Pain in Adults
Date:10/16/2007

Company Plans to File Supplemental New Drug Application with FDA in First

Quarter 2008

SOUTH SAN FRANCISCO, Calif., Oct. 16 /PRNewswire-FirstCall/ -- Anesiva, Inc. (Nasdaq: ANSV) today announced positive top-line results from its pivotal Phase 3 trial. The multi-center, randomized, double-blind study with 699 adult patients met its primary endpoint, demonstrating less venous procedural pain in those treated with Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal injection system compared to placebo (p= 0.003). Patients received Zingo or placebo one to three minutes prior to undergoing venous access procedures (IV insertions or blood draws). Zingo was found to be well tolerated in this patient population. Anesiva plans to file a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) in the first quarter of 2008 for the use of Zingo in adults.

"We've now shown that Zingo works in both the pediatric and adult populations. An expanded label from the FDA to include adults could greatly expand the market opportunity for us," said John P. McLaughlin, chief executive officer of Anesiva. "We have a world-class commercialization team that has significant efforts underway to prime the market for Zingo's introduction to pediatric hospitals in order to prepare for a strong launch and the development of a very successful business."

Zingo is already approved by the FDA to provide local analgesia prior to venipuncture or peripheral intravenous cannulation in children three to 18 years of age. Its onset of action is one to three minutes. Venous access procedures are among the most common procedures performed at a hospital, with more th
'/>"/>

SOURCE Anesiva, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

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. Antisoma Announces Further Data From ASA404 Ovarian Cancer Trial
3. Sygnis Pharma AG announces date for presentation of clinical results
4. Neose Announces Presentation of Positive Preclinical Data on GlycoPEGylated Factor VIIa at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
6. YM BioSciences Announces Secondary Efficacy and Safety Findings in Randomized Phase IIB Aerolef Trial
7. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
8. 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
9. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
10. AVI BioPharma Partner Cook Medical Announces Completion of Patient Enrollment for APPRAISAL Phase II Clinical Trial for Treatment of Cardiovascular Disease
11. Protox Announces Positive Clinical Data from Prostate Cancer Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2014)... Sept. 22, 2014  Sutro Biopharma today announced that ... one of 2014,s Fierce 15 biotechnology companies, designating it ... in the industry.  "Sutro has earned ... as well as industry partners for what promises to ... bispecifics," says John Carroll , editor of ...
(Date:9/22/2014)... YORK , Sept. 22, 2014 ... exclusive, global license agreement with Plasma Technologies LLC ... proprietary plasma fractionation process. Concurrently, the Company announced ... to strategically refocus and rebrand the company as ... a national listing for its common shares. ...
(Date:9/22/2014)... Research and Markets  has announced the addition of ... report to their offering. The ... professional and in-depth study on the current state of ... Chinese situation. The report provides a basic ... industry chain structure. The diclofenac market analysis is provided ...
Breaking Medicine Technology:FierceBiotech names Sutro Biopharma as one of its "Fierce 15" Biotech Companies of 2014 2FierceBiotech names Sutro Biopharma as one of its "Fierce 15" Biotech Companies of 2014 3Access Pharmaceuticals Announces Exclusive Global Plasma Therapeutics License, New Management And New Corporate Name 2Access Pharmaceuticals Announces Exclusive Global Plasma Therapeutics License, New Management And New Corporate Name 3Access Pharmaceuticals Announces Exclusive Global Plasma Therapeutics License, New Management And New Corporate Name 4Access Pharmaceuticals Announces Exclusive Global Plasma Therapeutics License, New Management And New Corporate Name 5Access Pharmaceuticals Announces Exclusive Global Plasma Therapeutics License, New Management And New Corporate Name 6Global and Chinese Diclofenac Industry Report 2014 2
... 24, 2011 Thomas Huxtable and his wife, Danielle, filed ... Inc. seeking compensation for injuries caused by the failure of ... has been recalled.  John David Hart of the Law Offices ... attorney representing Mr. and Mrs. Huxtable in the lawsuit filed ...
... Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX ), ... human disease, announced today that Pablo Lapuerta, M.D. has ... for directing clinical development of Lexicon,s drug candidates from ... Lapuerta has 15 years of pharmaceutical industry experience in ...
Cached Medicine Technology:DePuy Recalled Hip Device Lawsuit Filed in Austin, Texas 2Lexicon Pharmaceuticals Appoints Dr. Pablo Lapuerta Chief Medical Officer 2Lexicon Pharmaceuticals Appoints Dr. Pablo Lapuerta Chief Medical Officer 3
(Date:9/22/2014)... 22, 2014 Quincy Bioscience, one ... States, promotes National Self-Improvement Month this ... individuals should have access to self-improvement resources, especially ... The demand for products that preserve health is ... before. For over six years, Quincy Bioscience has ...
(Date:9/22/2014)... Scans of young children,s brains might help predict ... potentially allow doctors to identify those with dyslexia ... suggests. "Early identification and interventions are extremely ... most neurodevelopmental disorders," the study,s senior author, Dr. ... adolescent psychiatry at University of California, San Francisco ...
(Date:9/22/2014)... In a continued effort to support the ... launching an awareness campaign inspired by the ice bucket ... to raise awareness and funds for the cause. , ... the air and trying to catch it while blindfolded. ... nominee does not complete the challenge within 24 hours ...
(Date:9/22/2014)... (PRWEB) September 22, 2014 The struggles ... English proficiency (LEP) patients has been well-documented—reportedly, language barriers ... repeat visits to the emergency room and an increased ... , At Sanford Health, the largest medical facility ... a rising LEP population necessitated the need for ...
(Date:9/22/2014)... Tenn. (PRWEB) September 22, 2014 ... contact center and customer service solutions. , WHAT: ... is focused on customer care for the connected ... landscapes continue to offer new challenges and opportunities ... to helping attendees identify best practices, network and ...
Breaking Medicine News(10 mins):Health News:Quincy Bioscience Promotes National Self-Improvement Month 2Health News:Can Brain Scans Help Predict Young Children's Reading Abilities? 2Health News:Blind Egg Challenge Raises Awareness for Foundation Fighting Blindness 2Health News:Healthcare Cost Savings Case Study:Stratus Video Interpreting Assists Sanford Health System in Accommodating Increasing LEP Population,Saves a Predicted $100,000 Per Year 2Health News:Healthcare Cost Savings Case Study:Stratus Video Interpreting Assists Sanford Health System in Accommodating Increasing LEP Population,Saves a Predicted $100,000 Per Year 3Health News:Healthcare Cost Savings Case Study:Stratus Video Interpreting Assists Sanford Health System in Accommodating Increasing LEP Population,Saves a Predicted $100,000 Per Year 4Health News:LiveOps To Lead Panel Discussion At Customer Response Summit Memphis 2
... is associated with an increased risk of heart failure and ... concludes a study published on bmj.com today. ... continued use of rosiglitazone for most patients. Rosiglitazone and ... are widely used for the treatment of type 2 diabetes. ...
... year, 500,000 project to co-ordinate European and international ... treat malaria. The CRIMALDDI project (Coordination, Rationalisation ... Initiatives) is being led by the Liverpool School ... players in the antimalarial drug discovery fields including ...
... Having 45 million doses by Oct. 15 will still be ... Health experts do not believe that the delay in receiving ... protect Americans against the newly circulating virus. , But having ... than the originally anticipated 120 million doses, does throw a ...
... , MONROVIA, Calif., Aug. 20 STAAR Surgical Company ... minimally invasive ophthalmic products, today reported on the status of its application ... , , As anticipated, the Ministry of Health, Labour ... in Japan, at which time the STAAR Visian ICL products were considered ...
... ... and innovative charitable program that provides free hair restoration services to children suffering from ... ... , the world,s first online social network community dedicated to all-things hair loss has ...
... ... Sparsense, the developer of a novel image and signal processing ... firm. The exclusive partnership will allow the development of various custom ... applications. The new technology can be applied to MRI, MR video ...
Cached Medicine News:Health News:Diabetes drug linked to increased risk of heart failure 2Health News:LSTM to lead EU project to coordinate antimalarial drug research 2Health News:Swine Flu Vaccine Delay Manageable, Experts Say 2Health News:Swine Flu Vaccine Delay Manageable, Experts Say 3Health News:STAAR Surgical Reports Progress on Japanese Application for Approval of Visian(TM) Implantable Collamer(R) Lens (ICL(TM)) 2Health News:STAAR Surgical Reports Progress on Japanese Application for Approval of Visian(TM) Implantable Collamer(R) Lens (ICL(TM)) 3Health News:STAAR Surgical Reports Progress on Japanese Application for Approval of Visian(TM) Implantable Collamer(R) Lens (ICL(TM)) 4Health News:Hair Loss Website Launches Program for Children 2Health News:Mantaro Partners with Sparsense to Deliver High Performance Digital Image and Signal Processing Solutions 2Health News:Mantaro Partners with Sparsense to Deliver High Performance Digital Image and Signal Processing Solutions 3
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: