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news.Duska Therapeutics, a specialty pharmaceutical company, and DSM Pharmaceuticals, a business unit of DSM Pharmaceutical Products, have entered into a preliminary agreement to collaborate on the manufacture of commercial batches of ATPace for Duska's planned pivotal Phase III clinical trial in paroxysmal supraventricular tachycardia.
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Duska is in the process of modifying the proposed design of the Phase III clinical trial in accordance with the FDA’s comments and plans to submit a revised protocol to the FDA for special protocol assessment procedure approval.
Duska intends to initiate a single, prospective, double-blind, placebo-controlled and randomized trial in patients presenting to the emergency room with paroxysmal supraventricular tachycardia (PSVT) to demonstrate ATPace’s clinical safety and efficacy. Upon successful completion of the trial, Duska intends to file a new drug application.
ATPace, a stable liquid formulation of adenosine 5′-triphosphate for intravenous injection, is an investigational drug for the acute termination of PSVT. ATPace will be produced at DSM’s commercial facilities in Greenville, North Carolina.
Amir Pelleg, Duska’s president and chief scientific officer, said: “We chose DSM after a thorough analysis of their ability to manufacture ATPace according to our specifications and timeline, as well as meet all of the FDA’s requirements of a commercial drug manufacturer. We believe that DSM has an excellent working relationship with the FDA, experience with injectable drug products and a superior reputation in sterile manufacturing.”