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Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 5 of 5. This is the beginning of the thread.
Posted by saturn on September 14, 2007, at 20:46:15
Does anyone know anything more about this drug (currently in Phase III US Clinical Trials) or a possible approval date?
http://en.wikipedia.org/wiki/Valdoxan
It's mechanisms of action seem interesting.
Posted by jhj on September 15, 2007, at 2:59:12
In reply to valdoxan, posted by saturn on September 14, 2007, at 20:46:15
Novartis,which holds US licence for the drug says on its website that it plans to file NDA with FDA next year.EU resubmission for approval is likely to be filed at the end of this year or at the begining of the next year after it was refused approval last year by EMEA.Many studies have shown efficacy of valdoxan or agomelatine in treating depression.It has shown to be atleast as effective as current antidepressants with remarkabley benign side effects.Drop out rates due to side effects in the studies have been found not worse then placebo in controlled studies.Something is really wrong with EMEA and that is why it refused approval of valdoxan.
Posted by Phillipa on September 15, 2007, at 17:28:45
In reply to Re: valdoxan, posted by jhj on September 15, 2007, at 2:59:12
Wow from the quick read I did sounds like it's a lot like prozac without the side effects that is very encouraging for so many people. I admit to not reading whole thing but saw lack of side effects and that is exciting to me. Thanks Phillipa
Posted by cactus on September 15, 2007, at 22:21:30
In reply to Re: valdoxan, posted by Phillipa on September 15, 2007, at 17:28:45
Don't hold your breath people, the EU (european union) knocked it back and they are quite liberal to accepting new novel drugs
Posted by Phillipa on September 15, 2007, at 22:48:26
In reply to Re: valdoxan, posted by Phillipa on September 15, 2007, at 17:28:45
Knew it was too good to be true but why? Phillipa
This is the end of the thread.
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