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news.Madigan Army Medical Center and Neuren Pharmaceuticals have made plans to conduct a trial to determine the safety and efficacy of Glypromate, the only drug approved to reduce brain injury caused by out-of-hospital cardiac arrest.
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The trial will start in mid-2007 and will be managed by The Henry M Jackson Foundation for the Advancement of Military Medicine in consultation with the clinical investigators at Madigan.
An investigational new drug application will be submitted to the FDA by the army investigators rather than by Neuren. Neuren will provide the drug product as well as access to preclinical, clinical and regulatory documents related to Glypromate.
The company’s only financial commitment will be compensation to the Jackson Foundation for administrative costs incurred in coordinating the study. Neuren will retain all commercial rights to Glypromate.
Cardiac arrest involves the sudden cessation of heart function leading rapidly to neurological and other organ system damage. Among patients who survive, neurological damage occurs in up to 80% of survivors and causes cognitive impairment such as occurs in patients undergoing major cardiac surgery, the focus for Neuren’s upcoming phase III study with Glypromate. However recovery without residual neurological damage after cardiac arrest is rare.
Because of the serious nature of neurological impairment resulting from cardiac arrest and the lack of available drug therapy, Neuren intends to apply for fast track designation, which provides for accelerated clinical development and review.
Neuren estimates that the number of patients in the US that could be treated for out-of-hospital cardiac arrest and related indications is approximately 400,000 each year, which could represent a potential annual market of $800 million.