Psychotropic Drugs

FDA grants SPA for 2 pivotal phase III trials of CORLUX

Published in Pain and Central Nervous System Week, September 27th, 2004

Corcept Therapeutics, Inc., (CORT) announced that it has reached a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for the design of 2 pivotal phase III clinical trials evaluating CORLUX (mifepristone) for the treatment of the psychotic features of psychotic major depression (PMD).

The company plans on initiating the first of these trials immediately and expects the second to commence in the fourth quarter of 2004. Corcept anticipates having initial results from these studies available in the first half of 2006. CORLUX has been granted fast track designation for this indication.

"We are pleased to have...

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Source: Pain and Central Nervous System Week (2004-09-27)

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