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news.Cortex Pharmaceuticals has received approval from the German regulatory agency to proceed with the trial which will use alfentanil, an opiate analgesic. With this approval the enrollment of subjects into the dose response study evaluating the ability of CX717 to prevent respiratory depression caused by opiate analgesics has started.
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The study is a placebo controlled, double blinded, cross-over design with three doses of CX717 compared to placebo. Depending on the pace of subjects being enrolled, Cortex at this point believes that top-line data will be available from this study by the end of June, 2008.
If the German Ampakine studies are successful, pre-surgical or post- surgical administration of CX717 could improve the safety margin for giving these analgesic agents, which would provide a valuable tool for anesthesiologists and surgeons to optimize pain management in surgical patients. This would be true in high risk surgical patients such as those over the age of sixty-five, those with a history of sleep apnea, respiratory illnesses or obese patients.