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news.Cortex Pharmaceuticals has received approval from the German Federal Institute For Drugs And Medical Devices to initiate two Ampakine CX717 clinical studies for respiratory depression.
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These studies will assess whether the pre-administration of CX717 can prevent the development of respiratory depression (RD) induced by the potent Schedule II opiate agonist, alfentanil. The first study is a single dose, randomized, double-blind, placebo-controlled, two-period crossover design in sixteen healthy subjects. The primary study objective is to determine if CX717 can prevent RD while preserving the underlying desired analgesic effect of alfentanil.
The second study is a single dose, randomized, double-blind, placebo-controlled, two-period crossover design in twenty-four (eight subjects/dose) healthy subjects. Three different doses of CX717 will be assessed in this study, with the objective to determine an optimal dose for the prevention of RD in humans. The enrollment of patients will begin as soon as an additional approval from the German Federal agency that controls the use of opiate-type drugs is given.