Duska amends Ph III US ATPace trial plan

USA-based Duska Therapeutics has received comments from the Food and Drug Administration's Division of Cardiovascular and Renal Products on a synopsis of a proposed Phase III study of its lead drug, ATPace, for the acute treatment of a frequent cardiac arrhythmia called paroxysmal supraventricular tachycardia.

The US drugmaker is in the process of modifying the proposed trial in accordance with comments it received and plans to submit a revised protocol to the agency for Special Protocol Assessment procedure approval. Duska intends to initiate a single, prospective, placebo-controlled, randomized trial in patients presenting to the emergency room with PSVT to demonstrate ATPace's clinical safety and efficacy. Upon successful completion, Duska intends to file a New Drug Application under section 505(b)(2).