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Re: Velexity® (Gepirone ER) NOT APPROVABLE » Cecilia

Posted by Maria3667 on November 7, 2007, at 18:27:41

In reply to Re: Velexity® (Gepirone ER) NOT APPROVABLE » jrbecker76, posted by Cecilia on November 7, 2007, at 16:53:42

Cecilia,

Who knows:

"Fabre-Kramer and GSK are evaluating the response from the FDA to determine appropriate next steps"

according to their press release.

I sincerely hope Europe is still within their scope. Or designating it for another disorder than depression (like what happened to Strattera)...


> > > WHY? This was my last hope. Nothing else that I know of is coming out any time soon. Cecilia
> >
> > Demonstrating a strong efficacy in clinical trials with the 5-HT1a partial agonists have been a plaguing problem. Part of the issue might be the fact that this class of drugs might be more of a useful tool as an add-on rather than a stand-alone treatment in itself. Secondly, in particular with gepirone, it has been purported to be specifically efficacious in depressives with atypical features. It is doubtful that the gepirone clinical trials screened out non-atypical depressives in these trials.
> >
> > Another 5-HT1a drug (vilazodone), however, is pre-screening subjects and only admitting those with a particular genotype match (this particular genotype is known to have heightened efficacy with vilazadone in earlier trials). A third 5-HT1a partial agonist is PRX-00023, which is among a newly-engineered class of 1a agonists that are distinct from the older arylpiperazine class of HT1a compounds (buspirone, gepirone, etc). Data yielded from these trials in the coming year or so will either redeem the HT1a partial agonist's place in the treatment arsenal or finally put to rest their contended benefits.
> >
> >
> It'll be years if ever, before these come out. I looked up info for a clinical tral of vilazadone, but they were only taking people whose "current episode" of depression was less than 2 years. That makes no sense, atypical depression is chronic. Is there any country in which gepirone has been approved? Cecilia
>


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