Duska files Ph III ATPace protocol with FDA

California, USA-headquartered Duska Therapeutics has submitted for comment a synopsis of a proposed Phase III clinical study for its lead drug, ATPace (adenosine triphosphate) injection, to the Food and Drug Administration's Division of Cardiovascular and Renal Products.

Based on recent communications with the FDA, including a face-to-face meeting held on April 16, Duska believes that the proposed single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with paroxysmal supraventricular tachycardia 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 agency has expressed willingness to review and comment on the proposed trial design according to the Special Protocol Assessment procedure.