FDA Gives Green Light for ATPace Drug Pivotal Clinical Trial
June 2, 2009 - Cordex Pharma Inc. said today the FDA cleared the design of pivotal, phase 2b/3 clinical trials evaluating its lead product ATPace as an antiarrhytmic drug for the acute treatment of patients with paroxysmal supraventricular tachycardia (PSVT) under the special protocol assessment (SPA) process.
ATPace is a novel stable liquid formulation of adenosine 5-triphosphate (ATP). It is being developed as a therapeutic and diagnostic drug for the management of patients with cardiac arrhythmias. The company said ATP has been used in Europe for more than 50 years as the drug of choice for the acute termination of PSVT. During this extended period of time, formulations of ATP have manifested an excellent safety and efficacy profile, Cordex said.
The company intends to initiate prospective, double-blind, placebo-controlled and randomized clinical trials with its lead product ATPace in about 200 patients aimed at demonstrating clinical safety and efficacy sufficient to support a new drug application.
PSVT is an episodic, rapid, regular heart rate originating in the atria. The heart rate in PSVT can range from 150 to 250 beats per minute. There are approximately 570,000 persons with PSVT in the U.S. alone, with an estimated 89,000 new cases diagnosed each year. Patients with PSVT may report palpitations, pounding in the chest, chest pressure or pain, weakness, shortness of breath, or dizziness. Unless it self-terminates, PSVT patients need to seek medical intervention to terminate the arrhythmia.
For more information: www.cordexpharma.com