Posted by terrysb on June 22, 2009, at 18:23:48
In reply to Re: I don't want to go back on antidepressants » Alexanderfromdenmark, posted by Amelia_in_StPaul on June 22, 2009, at 11:20:40
> Also, are there any trials going on with Agomelatine?
>
There are four active phase 3 clinical trials of Agomelatine ongoing in the US. Two are past their completion date, one is completing in June and the fourth is completing in September. None of these trials is recruiting.Novartis has marketing rights in the US to the drug.
It has already been approved in Europe and is currently available in Russia and the Ukraine.
The one issue to be aware of with this medication is that there is a risk of liver injury and that there are cases where serum transaminases have been driven to high levels (e.g., 3X). They also mention that this has been primarily at the 50mg dosage level.
Due to the above the prescribing information suggests transaminase tests at initiation and then two more tests at 6 and 12 weeks.
poster:terrysb
thread:902496
URL: http://www.dr-bob.org/babble/20090620/msgs/902647.html