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Re: Getting back on Agomelatine (Valdoxon) » subconscious101

Posted by Nadezda on September 2, 2008, at 10:23:05

In reply to Getting back on Agomelatine (Valdoxon), posted by subconscious101 on August 31, 2008, at 21:50:17

Someone posted this on Wiki Answers:

~~ Agomelatine is currently being re-examined by the EMEA , after a previous failed attempt by Servier to gain approval in 2006. The concern at the time was that effiicacy for long term treatment of depression had not been demonstated. Recent studies have shown agomelatine is effective in long term treatment of depression and useful in anxiety disorders. The EMEA result is expected in mid 2008, so the drug may be available in europe in 2009 if there are no problems.
In the USA Novartis has the rights to develop Agomelatine and it is currently in phase III trials, submission to the FDA may occur by the end of 2008. If all goes well I guess end of 2009/2010 for release in the US is likely. ~~

It's almost impossible to find anything about agomelatine on the Novartis or Servier sites, which is strange. But there are five clinical trials, all not recruiting, all scheduled to be completed in the 2009, one of t hem not until October. Sounds like agomelatine won't be available until at least 2010.

Where did your pdoc call? Maybe if he called people at the different clinical trials, someone would be able to help. The locations are listed on the Novartis R&D site (you go to a US gov site, I think).

Wish I could think of something better.

Nadezda


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URL: http://www.dr-bob.org/babble/20080822/msgs/849875.html