Posted by jrbecker76 on June 21, 2008, at 1:09:04
In reply to finding agolmelatine, posted by kengwen on June 16, 2008, at 22:30:36
> HELP!! In 3 weeks my year will be over for my participation in a study group for Agomelatine. This has been the best medication to actually treat my severe depressive disorder. One year ago I was truly ready to give up. I had had enough. I participated under duress in one last clinical trial and l must say it saved my life. Agomelatine has been the only medication that has worked for me. Now my year is ending in a few weeks and I have been informed I can no longer receive this medication until FDA approval!! What am I supposed to do?? No SSRI has ever been effective for me and I cannot believe that my succes on Agomelitine will be suddenly stopped. I am scared to death (literally). Can anyone help me find where I can go to continue my medication regimine? Is it available anywhere?? HELP
Kengwen-
I certainly sympathize with your situation. I was also in an agomelatine study and did fairly well with it. Although I wouldn't go as far as to reflect that it was the most impactful med that I have taken, it has definitely been the one with the most negligible side effects.
Now that the 6-month study is over, I'm back on my old standby of a low-dose Cymbalta and Nefazodone cocktail. If available in the future though, I would definitely look to use it again within my regimen.
In terms of receiving authorization for "compassionate use" -- to retain access of a drug after the end of a clinical trial -- this is not typically implemented for most antidepressant studies. Such dispensations are usually reserved for end-of-life or orphan drug trials for indications such as cancer, ALS, and the like. Obviously, this is disappointing for many of us who find significant benefit from study drugs.
Unfortunately, agomelatine is not yet made available anywhere on the market yet. However, agomelatine does have a chance of coming to market soon though. In the E.U., it is rumored that the EMEA might rule on Servier's resubmission of its marketing application as soon as this month. If deemed positive, however, it would most likely take another few months for pricing and manufacturing discussions to be finalized before it comes on market in most Euro countries. In the U.S., as you probably know, Novartis will wrap up Phase III trials within the next couple of months. If the data turns out significant, plans would be followed through on to submit to the FDA by end of year. Given the FDA's recent track record, a good guess is that it will take another 9-12 months from the time of submission for an FDA response and market availability.
I hope this at least offers a little hope for things on the horizon.
Best,
JB
poster:jrbecker76
thread:835001
URL: http://www.dr-bob.org/babble/20080617/msgs/835744.html