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news.Duska Therapeutics has submitted for comment a synopsis of a proposed Phase III clinical study for its lead drug, ATPace, to the FDA's Division of Cardiovascular and Renal Products.
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Based on recent communications with the FDA, Duska believes that the proposed single, prospective, placebo-controlled, and randomized trial in patients presenting to the emergency room with paroxysmal supraventricular tachycardia (PSVT) 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 FDA has expressed willingness to review and comment on the proposed trial design according to the special protocol assessment procedure.
Duska has already compiled clinical data on the safety and efficacy of adenosine triphosphate (ATP), which is the active pharmaceutical ingredient in ATPace, in the treatment of patients with PSVT. In addition, Duska has its own safety database on ATPace, which was obtained in Phase I and II clinical trials.
Based on these data, Duska believes that upon successful completion of the proposed Phase III trial, it would have all the clinical data necessary to support the filing of the NDA for ATPace under section 505-b-2, the drafting of which has already commenced.