What's interesting about CORLUX is that it is also used for terminating pregnancy at similar doses. In that indication, it is known as RU-486. Remember the big controversy about it? FDA finally approved, long after its European counterpart did. Anyhow, this implies a pretty easy regulatory path for CORLUX if it can meet efficacy hurdles. I see the company is being pretty thorough about establishing that, by soon conducting pivotal trials to be completed in '06. This would imply a launch in '07.
Here's one of the earlier studies:
>>Biol Psychiatry. 2002 Sep 1;52(5):386-92.
An open label trial of C-1073 (mifepristone) for psychotic major depression.
Belanoff JK, Rothschild AJ, Cassidy F, DeBattista C, Baulieu EE, Schold C, Schatzberg AF.
Corcept Therapeutics Inc., Menlo Park, California 94025, USA.
BACKGROUND: The rationale for treating patients with psychotic major depression (PMD) with glucocorticosteroid receptor (GR) antagonists is explained. METHODS: Thirty patients with PMD, with Hamilton Rating Scale for Depression (HAMD-21) scores of 18 or greater, were assigned in an open label trial to receive 50 mg, 600 mg, or 1200 mg of mifepristone for 7 days. RESULTS: All the subjects completed the protocol; there were no dropouts. Side effects were mild and sporadic. Of 19 subjects in the combined 600- and 1200-mg group, 13 had a 30% or greater decline in their Brief Psychiatric Rating Scale (BPRS) scores, compared with 4 of 11 in the 50-mg group. In the 600- and 1200-mg group, 12 of 19 subjects showed a 50% decline in the BPRS positive symptom subscale, a more sensitive index for the symptoms seen in PMD, compared with 3 of 11 in the 50-mg group; 8 of 19 subjects in the 600- and 1200-mg group had a 50% decline in the HAMD-21, compared with 2 of 11 in the 50-mg group. CONCLUSIONS: These results suggest that short term use of GR antagonists may be effective in the treatment of psychotic major depression and that further blinded studies are warranted.<<
The Society of Biological Psychiatry is pretty close-fisted about abstracts from this meeting. Can't even find reference to the 2004 meeting on the web site.
Cheers, Tuck |
