Duska Therapeutics Plans 505(b)(2) NDA Filing Route for ...( LA JOLLA Calif. April 25 /- Duska...),Health
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
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