Posted by psychobot5000 on October 8, 2006, at 10:50:39
In reply to New FDA approvals: how long does this take?, posted by jealibeanz on October 8, 2006, at 8:03:38
According to what I've read, the prospects for approval for Gepirone and Valdoxan do not look good. Valdoxan was denied in the EU, and Servier had said other approvals depended on that process. I am disappointed. One article seemed to suggest that there was little reason Gepirone's application would be viewed differently the second time.
But PRX-00023's prospects look pretty good. Recently finished a stage III trial for anxiety, in which it failed to produce positive results that were large enough to be statistically acceptable--however, the secondary study results, on depression, were quite good. The developers said they planned to regear their approval strategy toward depression, and that was a week or two ago.
There are a bunch of other promising drugs a little further back in development. If you haven't been to this page, you should check it out. The information can be slightly outdated, but it's otherwise good.
http://www.neurotransmitter.net/newdrugs.html
> I know there are a few novel drugs in phase III for anxiety and depression:
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> - Gepirone ER by Fabre-Kramer, is a 5-HT1A partial agonist, has completed phase III and has an amended NDA scheduled to be submitted in mid- 2006.
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> - SR 58611 by Sanofi-Aventis, is a beta-3-adrenoceptor agonist, currently in Phase III.
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> - Valdoxan (agomelatine, S-20098)by Novartis, is a 5-HT2C antagonist, 5-HT2B antagonist, melatonin M1/M2 receptor agonist, currently in Phase III.
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> - Saredutant(SR 48968), a NK2 antagonist, by Sanofi-Aventis, is currently in Phase III.
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> - PRX-00023 5-HT1A agonist, sigma receptor antagonist. by Predix, is currently in Phase III for ADHD and anxiety(still in phase II for depression).
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> I'm sure there are more, but these are the only ones I've come across at this time. It's so difficult to get concrete information!
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> Anyway, I'm wondering how long it would be expected for any of these medications to be approved and put on the market. I realize this process is slowed when the FDA reviews an application, and then asks for further studies to be done. Assuming we have a perfect world (HA!), and this does not happen, how long does it usually take for phase III drugs to be approved?
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> I'm especially interested in Gepirone since it has actually completed phase III, submitted an NDA initially, then was asked to provide further information. They now appear to be in the process of submitting their 2nd NDA. I believe it has been submitted at this time, although I could be incorrect.
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> I don't know that this particular drug would be my best bet, but who knows. They claim to have few side effects (sexual, weight, apathy, lethargy) in comparison to SSRI's (yay! people are actually admitting the SSRI's are not all they're cracked up to be!). However, this appears to be the only hope within the next year or so.
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poster:psychobot5000
thread:692938
URL: http://www.dr-bob.org/babble/20061003/msgs/692958.html