Duska is in the process of modifying the proposed design of the Phase 3 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 PSVT to demonstrate ATPace's clinical safety and efficacy. Upon successful completion of the trial, Duska intends to file a New Drug Application under section 505(b)(2).
"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," stated Amir Pelleg, PhD, Duska's President and Chief Scientific Officer. "We believe that DSM has an excellent working relationship with the FDA, experience with injectable drug products, and a superior reputation in sterile manufacturing," he added.
"We are delighted to be supporting Duska Therapeutics in bringing this important potential new therapy to market," said Hans Engels, President and Business Unit Director for DSM Pharmaceuticals, Inc. "Through our collaboration, we have experienced first-hand, Duska's commitment to excellence in serving a market with the need for improved treatments."
"We are excited to add Duska to our customer base and look forward to the anticipated launch of this key product, as well as the potential future growth with Duska," remarked Laura Parks, Senior Vice President, Marketing & Sales for DSM.
About Duska Therapeutics, Inc.
Duska Therapeutics, Inc., (Duska) is a specialty pharmaceutical company
that develops new cardiovascular medicines based upon the emerging
pharmacology of adenosine triphosphate (ATP) and nitric oxide (NO). These
two molecules play critical r
'/>"/>
| SOURCE Duska Therapeutics, Inc. Copyright©2008 PR Newswire. All rights reserved |