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news.The FDA has told Cortex Pharmaceuticals that it will not approve the company's investigational new drug application for a Phase IIb study of CX717 in attention deficit hyperactivity disorder.
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The denial is based on results of animal toxicology studies filed by Cortex. As a result, the company has requested that the division of psychiatry products of the FDA inactivate its IND application for attention deficit hyperactivity disorder (ADHD).
However, California-based Cortex said that it will not formally withdraw the investigational new drug (IND) application at this time, in order to evaluate the formal response from the FDA. Cortex said that it will weigh the potential for providing additional data if the potential exists for re-activating the IND at a later date, although it does not believe it likely that a resubmission will occur at this point.
Depite the setback, Cortex said that it will continue to develop CX717 for the acute treatment of respiratory depression and in its Alzheimer’s disease PET scan study.