Posted by yxibow on February 20, 2006, at 2:58:37
In reply to Re: Agomelatine (Valdoxan) Not out yet :-( » Tom Twilight, posted by Phillipa on February 19, 2006, at 20:23:07
> What category of ad is it and how come not the USA? Yes it does sound too good to be true. Fondly, Phillipa
http://www.medicalnewstoday.com/medicalnews.php?newsid=22334
5 Apr 2005
"Valdoxan was discovered and developed by Servier. The drug is currently in Phase III and a registration dossier for an indication in MDD was recently submitted to the European Regulatory Agency (EMEA)."
Phase III trials are the final human trials before marketing, and usually involve around 5000 patients around the world. The EMEA is roughly equivalent to the FDA.
It is a MT1 and MT2 agonist (melatonin agonist) antidepressant. Servier doesn't usually submit that many drugs to the FDA from what I can recall. Who knows.
poster:yxibow
thread:611047
URL: http://www.dr-bob.org/babble/20060219/msgs/611305.html