Posted by nothing on July 19, 2008, at 1:34:27
In reply to finding agolmelatine, posted by kengwen on June 16, 2008, at 22:30:36
heh... I read the outline for that 52week study with Agomelatine.. Honestly you really should've paced yourself by taking 1/2 the dose for the first half of the study, then lie/complain it wasn't working well enough then they might have upped your dose to 50mg, so then you'd have double the supply to pace yourself with which could've lasted more than enough to get you through to the approval date if that even occurs. Yea it seems wrong but truth is no one really cares about the discomfort you'll go through when you run out of the Ago as you're about to find out. If you don't fend for yourself no one will, after all they aren't the ones who are going to hurt and actually feel pain when your medication runs out. My guess is that EMEA's CHMP will prob approve Valdoxan this time around (last time it was rejected most likely bc of financial influences from investors for existing blockbuster pharmas like Lundbeck's Lexapro, after all, drugs with unexpired patents can still make money so if you're an investor why bother competing with yourself?) with sluggish FDA approval to follow about a half a year as it has to do its own useless investigation, in my estimate putting Agomelatine's USA release sometime around early 2009 (+/- a few months), if all goes perfectly. You should probably be thankful you were even lucky enough to get into that study. I tried hard to get in but research docs are b-holes and the criteria they must follow makes it almost impossible to get in, they seem to prefer females too. Just one more reason to dislike government bureaucracy and all these USELESS regulatory agencies. It makes me sick to my stomach that ritanserin very similar in functionality to agomelatine could make an afforable and effective add-on drug yet has no chance of ever being sold as a drug. Looks like you will have to wait like the rest of us. On the bright side, agomelatine may never be approved due to market pressure from existing drugs. Therefore, the discomfort you're likely about to feel won't be pointless. I don't mean to sound like a jerk, I can def sympathize AND empathize with what you must be going through right now. You probably just didn't know what to expect going into this study and now it has come to the end of the study and it's cut-off time. One thing that MIGHT help, but prob not too much. If Ago improved your sleep you may be able to substitute Ramelteon (Rozerem) for the time being. It won't have the antidepressant benefit but it may take the edge off anxiety and improve sleep regularity. However, this is def something to discuss with a pdoc rather than take my word. My guess is that going from Ago to Rozerem is likely to be somewhat of a letdown, but prob better than cold-turkey. This almost makes me glad I didn't get into the study as I wouldn't want the possibility of starting Ago, having to stop it, then restarting it up later only to find that it doesn't work the second time around. I really hope this doesn' turn out to be the case for you! Good luck and thanks for your contribution in getting Agomelatine approved for the rest of us! Hopefully that research center helped pay for your gas/parking during your checkup visits.
poster:nothing
thread:835001
URL: http://www.dr-bob.org/babble/20080718/msgs/840679.html