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Cortex CX717 ADHD clinical hold

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

A clinical hold placed on Cortex' investigational attention deficit hyperactivity disorder agent CX717 is based on preclinical animal data, the firm says April 13 after receiving a letter from FDA explaining the decision. "Based on the terms in the letter, the company has begun the process to arrange for discussions with the appropriate experts within the agency to translate the request into specific acute preclinical studies related to the issues and recommendations provided by the agency," the Irvine, Calif. firm states. Cortex' development focus is its proprietary Ampakine compounds, one of which is CX717. The firm has multiple patents for the agents, which bind to the AMPA receptors to increase signal strength in connections between brain cells...

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