CORTEX SUBMITS RESPONSE TO FDA ON ADHD DRUG CLINICAL HOLD
Cortex Pharmaceuticals has submitted a complete response to each of the points raised by the FDA regarding certain toxicology issues pertaining to its lead Ampakine compound, CX717. Under regulation, the FDA is required to respond within 30 days as to whether it will remove or maintain the clinical hold.
"Cortex has worked diligently over the past few months to address the concerns of the FDA," said Roger Stoll, president, CEO and chairman of Cortex. "While we believe the submitted data is sufficient to release the hold and resume our clinical trials program on CX717, that decision is ultimately one that will be made by the FDA."
The company has met the timeline it defined at its annual shareholder meeting in May for conducting additional toxicology studies required by the FDA and submitting the complete response by early September. Prior to the clinical hold being placed on CX717, the company had reported positive results of a Phase IIa study for the treatment of adults with attention deficit/hyperactivity disorder (ADHD).
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