Cortex Pharmaceuticals says that the FDA has turned thumbs down on its INDA for a Phase IIb trial of CX717 for ADHD after reviewing its animal toxicology studies. Cortex says its asking FDA officials to inactivate the INDA for that indication. Studies of CX717 will go ahead for respiratory depression and its Alzheimer's disease PET scan.
- see the release [1]Â from Cortex
Related Articles:
Cortex gets green light to resume Alzheimer's trials. Report [2]
FDA hold lifted on Cortex drug. Report [3]
Cortex shares plunge on CX717 failure. Report [4]
Cortex names Varney new COO. Report [5]
Read more on:Â ADHD [6]
Links:
[1] http://www.fiercebiotech.com/press-releases/press-release-fda-rejects-cortex-pharmaceuticalss-request-study-drug-candidate
[2] http://www.fiercebiotech.com/story/cortex-gets-green-light-resume-alzheimers-trials/2007-07-17
[3] http://www.fiercebiotech.com/story/spotlight-fda-hold-lifted-on-cortex-drug/2006-10-09
[4] http://www.fiercebiotech.com/story/cortex-shares-plunge-on-cx717-failure/2006-06-22
[5] http://www.fiercebiotech.com/story/c-amp-l-cortex-names-varney-new-coo/2006-02-01
[6] http://www.fiercebiotech.com/tags/adhd