Healthcare Industry News:  ADHD 

Biopharmaceuticals Regulatory

 News Release - March 7, 2008

Cortex Receives Approval from German Regulatory Authority to Proceed with Two Clinical Trials for AMPAKINE(R) CX717 for the Acute Treatment of Respiratory Depression Due to Opiate Analgesics

CX717 Does Not Affect the Analgesic Properties of Opiates

IRVINE, Calif.--(HSMN NewsFeed)--Cortex Pharmaceuticals, Inc. (AMEX: COR,, has received approval from the German Federal Institute For Drugs And Medical Devices (BfArM) to initiate two AMPAKINE® CX717 clinical studies. 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. Such affects have already been demonstrated in animals. Currently available opioid reversal agents, such as naloxone (Narcan®), also reverse the analgesic effect of opioids, which is a major drawback. Hence, an agent that enhances the safety of using opiate drugs by preventing the risk of RD, but preserves the analgesic effects of the opiates, can significantly improve pain management in patients.

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.

Studies of CX717 in animal models have demonstrated that the drug can be used both to prevent and to rescue the animal from opiate-induced RD. It also has been shown that a dose response effect on RD can be obtained after oral administration in animal models. While the medical need for opiate drugs such as fentanil and alfentanil that permit maximal pain relief is clear, unfortunately there is a significant risk of inducing RD with these agents, which can be life threatening. Cortex believes that the acute use of a drug such as CX717 can improve the safety margin for giving powerful analgesics after painful surgical procedures and would provide a valuable tool for anesthesiologists and surgeons to optimize pain management in surgical patients. This would be especially 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.

In his presentation at the February 19, 2008 Roth Capital Partners Conference, Dr. Roger G. Stoll, CEO of Cortex, estimated that Cortex should have preliminary results from one study by the end of the second quarter 2008 and the other by early in the third quarter 2008. A replay of Dr. Stoll’s presentation on the unique mechanism of action, market potential, and regulatory strategy for the use of CX717 to treat RD will be available until March 20, 2008 and can be accessed by logging onto

About Cortex

Cortex Pharmaceuticals, Inc. is a neuroscience company located in Irvine, California that focused on the discovery and clinical development of AMPAKINE® molecules, a platform technology that represents a new approach to treating psychiatric disorders, neurological diseases and brain mediated breathing disorders. The Company has pioneered a novel class of proprietary pharmaceuticals called AMPAKINE compounds that positively modulate the AMPA-type glutamate receptor complex, amplifying the effect of the most prominent brain neurotransmitter, glutamate at the synapse, leading to excitation of brain circuits that appear to affect memory, cognition and a unique brain stem structure thought to be responsible for inspiratory drive and the maintenance breathing rhythm.

Many neurodegenerative disorders could potentially benefit from enhanced binding of glutamate by AMPAKINE compounds, which has been demonstrated in standard animal models of Alzheimer’s, Huntington’s diseases, Parkinson’s disease and potential uses in many other neurodegenerative diseases. Many psychiatric diseases, including Attention Deficit Hyperactivity Disorders (ADHD), depression, and schizophrenia occur as a result of imbalances in the brain’s neurotransmitter system. Proof of Concept in adult ADHD patients has been demonstrated with CX717. Cortex currently has an alliance with Schering-Plough (formerly Organon) for the treatment of schizophrenia and depression. In 2006 Cortex terminated its research collaboration with Les Laboratoires Servier and in turn worldwide rights to neurodegenerative diseases, sexual dysfunction, and anxiety were returned to Cortex. Servier retained three compounds from the research collaboration and may develop them for neurodegenerative diseases, sexual dysfunction, and anxiety in all markets in the original license. For additional information regarding Cortex, please visit Cortex Pharmaceuticals’ Website at

Forward-Looking Statement

Note - This press release contains forward-looking statements concerning the Company's research and development activities. The success of such activities depends on a number of factors, including the risks that the Company's proposed compounds may at any time be found to be unsafe or ineffective for the indications under clinical test and that clinical studies may at any point be suspended or take substantially longer than anticipated to complete. As discussed in the Company's Securities and Exchange Commission filings, the Company's proposed products will require additional research, lengthy and costly clinical testing and regulatory approval. AMPAKINE compounds are investigational drugs and have not been approved for the treatment of any disease.

Source: Cortex Pharmaceuticals

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