Navigation Links
Duska Therapeutics Plans 505(b)(2) NDA Filing Route for ATPace(TM)
Date:4/25/2008

LA JOLLA, Calif., April 25 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska" or the "Company"), a biotechnology company developing medical products based on adenosine 5'-triphosphate (ATP) and P2 receptor-related technologies, announced today that the Company's management and clinical and regulatory consultants met on April 16 with members of the United States Food and Drug Administration (FDA) Division of Cardiovascular and Renal Products. The purpose of the meeting was to discuss the appropriate regulatory pathway for filing a marketing application of ATPace(TM) as an antiarrhythmic drug for the acute termination of paroxysmal supraventricular tachycardia (PSVT).

Based on discussions held during the meeting and prior written communications between Duska and the FDA, the Company believes that the FDA would consider a New Drug Application (NDA) under section 505(b)(2) for ATPace(TM) subject to additional clinical data to be furnished by the Company. The 505(b)(2) NDA relies in part upon relevant published data obtained by entities other than the Company.

Dr. James Kuo, Duska's Chairman and CEO, said, "I am pleased to report that this meeting with the FDA was both positive and constructive. Together with our CRO, Cato Research, Inc., we have already commenced activities aimed at the generation of the supplemental data requested by the FDA. The 505(b)(2) NDA filing provides an expedited route for potential approval of ATPace(TM)," he added.

Dr. Amir Pelleg, Duska's President and Chief Scientific Officer, stated, "It has been our goal to commercialize the first ATP-based drug in the United States and I believe we are now much closer to attaining that goal as a result of this meeting. Formulations of ATP, which is the active ingredient in ATPace(TM), have been used for over 50 years in Europe in the treatment of PSVT. I am confident that our drug would manifest a safety and efficacy profile similar to that
'/>"/>

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

Page: 1 2 3

Related medicine news :

1. Echo Therapeutics and Cato BioVentures Sign Right of First Offer Agreement for Dermatology Products and Transdermal Drug Delivery Technologies
2. CV Therapeutics to Announce 2008 First Quarter Financial Results on Friday, April 25, 2008
3. Precision Therapeutics Adds 8 Million Covered Lives Under Contract
4. Hyperion Therapeutics Elects Lota Zoth to Board of Directors
5. Gamma Secretase Modulators Show Promise in Alzheimers Disease Animal Model Efficacy Studies, According to Research Conducted by TorreyPines Therapeutics
6. Antisense therapeutics scientist out to pull more big deals
7. Vista Partners Initiates Coverage on Arana Therapeutics (ASX: AAH; AIM: AAHx)
8. Transition Therapeutics to Present at Cowen & Company 28th Annual Healthcare Conference
9. Juvaris BioTherapeutics, Inc. Announces the Appointment of Grant E. Pickering as Chief Executive Officer
10. Echo Therapeutics Announces Positive Results from Symphony(TM) Transdermal Continuous Glucose Monitoring System Study at Tufts Medical Center
11. Cell Therapeutics, Inc. (CTI) Reports Recent Accomplishments and 2007 Fourth Quarter and Year End Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/14/2014)... treat children with uncomplicated acute appendicitis is a reasonable ... fewer missed school days, according to a pilot study. ... Hospital and published online April 12 in the ... the first prospective study on nonoperative management of acute ... , Researchers enrolled 77 patients age 7 to 17 ...
(Date:4/14/2014)... 2014, Perth, Australia. Drug discovery company Proteomics International ... of a companion diagnostic (CDx) test with the ... The research team authenticated the panel of biomarkers ... samples. Seven biomarkers were validated at high stringency ... The mass spectrometry data was then cross-validated using ...
(Date:4/14/2014)... 2014) When it comes to the cost and ... Patients get the best care when they are treated ... extensive experience in their current job, according to a ... and Columbia Business School. The study was published in ... Applied Economics . , The review of more ...
(Date:4/13/2014)... STANFORD, Calif. A low-cost empowerment program for ... and sexual harassment of these girls, who live ... and are frequently attacked, a large new study ... Stanford University School of Medicine, Lucile Packard Children,s ... No Worldwide, validated the program,s effectiveness in combating ...
(Date:4/11/2014)... the processes that control brain cell production could pave ... brain-related disorders. , Scientists have gained new understanding of ... how and when nerve and brain cells are formed ... and keeps it healthy. Their findings could help explain ... which is a fundamental characteristic of many diseases including ...
Breaking Medicine News(10 mins):Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 2Health News:Antibiotics alone are a successful treatment for uncomplicated acute appendicitis in kids 3Health News:Longer nurse tenure on hospital units leads to higher quality care 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 2Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 3Health News:Empowerment program greatly decreases incidence of rape, Stanford/Packard-led study finds 4
... INDIANAPOLIS An orphan drug originally used for HIV treatment ... additional sensitivity and pain from opioid use. The study by ... in the March 25, 2011 issue of Brain, Behavior ... in animal models may ultimately make morphine a safer and ...
... , THURSDAY, March 24 (HealthDay News) -- Children ... control more quickly and accurately than those without the ... characterized by repeated involuntary sounds and physical movements called ... or -- in rare adult cases -- blurting out ...
... is available in French and Spanish . ... of Granada , belonging to the Laboratorio de Ciencias de la ... night vision, and the tool required to implement it, which has ... Software Halo v1.0, and a computer where the mouse is used ...
... Nick Harvey of the MRC Lifecourse Epidemiology Unit, Southampton, ... of Lige, Lige, Belgium were presented with the ESCEO ... at a ceremony held during the European Congress on ... Spain. The Awards, valued at 2,500, recognize young ...
... China, investigated eye movements in Chinese and British people to ... how they compare between different human populations. They found ... British people, is much more common in Chinese people, suggesting ... different populations. Tests of eye movements can ...
... Even mild stress can cause long-term disability that prevents people ... been known that mental disorders can be a cause of ... forms of stress should be taken more seriously, according to ... Kingdom, and colleagues. The study included over 17,000 employed ...
Cached Medicine News:Health News:A safer, more effective morphine may be possible with Indiana University discovery 2Health News:Children With Tourette Syndrome Have Better Motor Control, Study Finds 2Health News:Researchers develop a halometer that tests alterations in night vision 2Health News:Researchers develop a halometer that tests alterations in night vision 3Health News:Eye movement differs in British and Chinese populations 2Health News:Even Mild Stress Can Lead to Disability, Study Says 2
(Date:1/15/2014)... , Jan. 15, 2014  Research and Markets ... the "Dental Consumables Market - Global Industry ... - 2018" report to their offering. ... ) Dental consumables are products which are ... impairments, for tooth restoration and in treatment of ...
(Date:1/15/2014)... , Jan. 15, 2014  Novation, the leading ... company, awarded several new IT value-added reseller (VAR) ... hospital organizations with IT goods and services at ... agreements, as well as value-added services such as ... New Novation agreements were awarded to ...
(Date:1/15/2014)... DUBLIN , January 15, 2014 ... that it has waived the Office of Fair Trading (OFT) ... the outstanding shares of ViroPharma Incorporated (NASDAQ: VPHM).   ... no longer conditional on OFT approval, and Shire expects to ... currently scheduled expiration time, subject to the satisfaction of all ...
Breaking Medicine Technology:Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 2Dental Consumables Market - Global Industry Analysis, Size, Share, Growth, Trends And Forecast, 2013 - 2018 3New Novation Information Technology VAR Contracts Offer Significant Savings to Hospitals 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 2Shire Waives OFT Condition Relating to the Acquisition of ViroPharma Inc. 3
... Products Company, Inc. has announced the addition of Florida ... Systems. Florida Metrology, based in Jupiter, ... Systems is a line of highly accurate portable metrology ... across the United States. Tim Row of Florida Metrology ...
... FOUNTAIN HILLS, Ariz., Dec. 8, 2010 Sunridge International ... that Ameco Medical is preparing to start the short ... Ameco Medical Equipment L.L.C., Sunridge,s exclusive distributor for ... Bores, Sunridge,s medical consultant, to attend the start of ...
Cached Medicine Technology:Florida Metrology To Distribute OASIS Inspection Systems 2
... offers accuracy, speed, ease of use, ... is an Auto Refractor/Keratometer with both ... elevation, automatic alignment, focusing, printing, high-speed ... other features that have made the ...
Neomycin and Polymyxin B Sulfates and Hydrocortisone otic suspension, USP is a sterile antibacterial and anti-inflammatory suspension for otic use....
Neomycin and Polymyxin B Sulfates and Hydrocortisone ophthalmic suspension is a sterile antimicrobial and anti-inflammatory suspension for ophthalmic use....
Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment is a multiple dose anti-infective steroid combination in sterile ointment form for topical applications....
Medicine Products: