LA JOLLA, Calif., July 23 /PRNewswire-FirstCall/ -- Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska") announced today that it has submitted for comment a synopsis of a proposed Phase 3 clinical study for its lead drug, ATPace(TM), to the U.S. Food and Drug Administration's (the "FDA") Division of Cardiovascular and Renal Products.
Based on recent communications with the FDA, including a face-to-face meeting held on April 16, 2008, Duska believes that the proposed single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with paroxysmal supraventricular tachycardia (PSVT) should be sufficient to demonstrate clinical safety and efficacy. The proposed primary endpoint of the study is dose-dependent conversion of PSVT to normal sinus rhythm. The FDA has expressed willingness to review and comment on the proposed trial design according to the Special Protocol Assessment (SPA) procedure.
PSVT is a rapid regular heart rate originating in the atria. It has been estimated that there are 89,000 new cases of PSVT per year in the United States alone. PSVT is one of the most common cardiac arrhythmias.
Duska has already compiled clinical data on the safety and efficacy of adenosine triphosphate (ATP), which is the active pharmaceutical ingredient in ATPace(TM), in the treatment of patients with PSVT. In addition, Duska has its own safety database on ATPace(TM), which was obtained in Phase 1 and 2 clinical trials. Based on these data, Duska believes that upon successful completion of the proposed Phase 3 trial, it would have all the clinical data necessary to support the filing of the NDA for ATPace(TM) under section 505(b)(2), the drafting of which has already commenced.
Dr. James Kuo, Duska's Chairman and CEO, said, "After our recent
interactions with the FDA, I believe we have a clear plan to acquire all
the data that would be necessary to support the filing of a NDA for
|SOURCE Duska Therapeutics, Inc.|
Copyright©2008 PR Newswire.
All rights reserved