DUSKA THERAPEUTICS PLANS NDA 505(B)(2) FILING FOR ATPACE.Duska Therapeutics, Inc. (BULLETIN BOARD: DSKA), La Jolla, Calif., a biotechnology company developing medical products based on adenosine 5'-triphosphate (ATP ATP: see adenosine triphosphate. ATP in full adenosine triphosphate Organic compound, substrate in many enzyme-catalyzed reactions (see catalysis) in the cells of animals, plants, and microorganisms. ) and P2 receptor- related technologies, has announced that the company's management and clinical and regulatory consultants met on April 16 with members of the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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 antiarrhythmic /an·ti·ar·rhyth·mic/ (-ah-rith´mik) 1. preventing or alleviating cardiac arrhythmias. 2. an agent that so acts. an·ti·ar·rhyth·mic adj. drug for the acute termination of paroxysmal supraventricular tachycardia paroxysmal supraventricular tachycardia Supraventricular tachycardia Cardiology Tachycardia triggered sporadically in the myocardium above the ventricles; PSVT is most common in younger subjects with normal hearts Risk factors Smoking, caffeine, stress, alcohol (PSVT PSVT paroxysmal supraventricular tachycardia. ). 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 (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , 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 of the European formulations." About ATPace(TM) ATPace(TM) is Duska's investigational intravenous pharmaceutical formulation of ATP for the acute treatment of paroxysmal supraventricular tachycardia (PSVT). The bradycardic bradycardic adjective Referring to bradycardia (heart rate slowing) effect of ATP, in particular its transient blockade of atrio-ventricular nodal conduction, has been shown in multiple published clinical studies to terminate re-entrant (programming) re-entrant - Used to describe code which can have multiple simultaneous, interleaved, or nested invocations which will not interfere with each other. This is important for parallel processing, recursive functions or subroutines, and interrupt handling. PSVT involving the atrio-ventricular node. About PSVT PSVT (paroxysmal supraventricular tachycardia) is a rapid regular heart rate originating in the atria. It has been estimated that there are 89,000 new cases per year in the United States alone. PSVT is one of the most common cardiac arrhythmias. About Duska Therapeutics, Inc. Duska Therapeutics, Inc., based in La Jolla, California, is an emerging biotechnology company that is focused on the development of therapeutic, medical device and diagnostic products related to adenosine 5'-triphosphate (ATP) and cell-surface P2 receptors (P2R). Duska owns or has exclusive license rights to a number of proprietary products, four of which are currently in various stages of development for the treatment and diagnosis of certain cardiac arrhythmias, enhancement of sperm motility, treatment of chronic obstructive pulmonary disorder, and mitigation of the toxic effects of radiation exposure. For more information, visit http://www.duskatherapeutics.com or call 858/551-5700. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion