FDA News

Duska Therapeutics Plans Meeting with the FDA on ATPace

(March 11, 2008)--Duska Therapeutics, a biotechnology company developing medical products based on adenosine 5'-triphosphate (ATP) and P2 receptor-related technologies, announced today that its senior management and consultants are scheduled to meet with representatives of the U.S. Food and Drug Administration's (FDA) Division of Cardiovascular and Renal Products in April to discuss the regulatory pathway for obtaining marketing approval of ATPace, an intravenous formulation of ATP.

Duska requested a Type C advisory meeting with the FDA to present, discuss and obtain answers to several questions submitted by the company related to the regulatory pathway of ATPace(tm). The company intends to file an NDA under Section 505(b)(2) of the FDA for ATPace(tm) as an antiarrhythmic drug for the conversion of paroxysmal supraventricular tachycardia (PSVT) to normal sinus rhythm. The company believes that the meeting with the FDA will yield a pathway for eventual marketing approval of the drug.

Currently, Duska has an Investigational New Drug application with the FDA on ATPace(tm) and has collected clinical data on ATPace(tm) in diagnosing bradycardic neurally-mediated syncope.

"Together with our CRO, CATO Research, we are looking forward to having a productive meeting with the FDA that we expect will enable us to bring ATPace to the U.S. market in an expeditious manner" said Dr. James Kuo, Duska's Chairman and Chief Executive Officer. "Duska's founders played a critical role in introducing the first adenosine product to the market, and we seek to put the first ATP pharmaceutical product on the U.S. market," he added.

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