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Re: RU 486 - what happened to fast tracking?

Posted by SLS on June 27, 2008, at 22:31:50

In reply to Re: RU 486 - what happened to fast tracking?, posted by undopaminergic on June 27, 2008, at 20:53:41

> > Is this drug going anywhere?
> >
> > ??
> >
> > Linkadge
>
> I think it's already on the market, but for other conditions than psychiatric ones.
>
> I'm not particularly impressed with what I've read about it so far. It seems questionable whether it's reasonably effective even for the limited purpose it's being studied for: psychotic depression. It may be of value in certain individual cases, but FDA approval isn't needed for that - it might as well be prescribed off-label.

I am in agreement with Undopaminergic regarding my impression of mifepristone (RU-486). If you are interested in trying it, you must go through the Feminist Majority Foundation. There is quite a bit of paperwork involved. It must be applied for via an IND. It cannot be prescribed off-label at this point. There are special regulations in place that proscribe doing so. Only a doctor may obtain and administer the drug.

I did not respond at all to mifepristone, except that I felt flat and "washed-out" at the end of the 7 day trial. I was disappointed in Alan Schatzberg, MD, for having such a personal interest in the approval of this drug. He would stand to profit from it. His studies represent a conflict of interest. He's a real nice guy, though. Messy.


- Scott

 

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