Posted by Elizabeth on January 14, 2002, at 19:15:16
In reply to Selegiline Patch FDA Update, posted by tom dowd on January 10, 2002, at 14:26:52
> I spoke to Dr. Bodkin last week and he told me that the FDA should approve or not approve the patch within 4 months.
Eh. I've often heard things like this (including from Dr. Bodkin), and I'm somewhat skeptical -- the FDA always seems to find some reason to stall the approval of any new drug (except the ones that don't really do anything, of course < g >).> I then asked if there would be any possible problems from the trials that might cause them to deny approval. He said that there might be concern that the patch had caused some "skin irritation" during the trials.
I think this is a common side effect of transdermal delivery systems. I hope it won't impede approval.
> Wouldn't it be ironic if they denied the patch approval because it might cause skin irritation while allowing all the other maois to be marketed with the dangerous interactions possible just by eating cheese?
The old MAOIs were grandfathered in -- they were on the market before the FDA existed.
> He was careful not to give any indication of his personal opinion as to whether or not he thought it would or would not be approved.
Heh -- see my above complaint about the FDA. They can be finicky.
> I've read that selegeline enhances sex drive and also that it causes sexual dysfunction. Which is it?
I've heard that it's less likely to cause sexual problems than the other MAOIs are (Nardil and Marplan are probably the worst ones in this regard, Parnate doesn't seem to be so much of a problem, not sure about moclobemide), but that doesn't mean it never happens. It does have l-amphetamine metabolites which might enhance sexual functioning for some people.
Spike:
> I thought RIMA MAOIs were not marketed in the US because of lack of efficacy .... studies for depression were not that conclusive so the drug companies abandoned approval? Is that wrong?The rumor I heard was that, in the case of moclobemide at least, Roche decided not to bother marketing it in the U.S. because the market was already flooded with SSRIs and such. I'm inclined to believe it because I seem to recall other situations in which Roche has been kind of chicken about new drugs (especially in the U.S., where it's particularly hard to get them approved), if you ask me -- it's like they had Librium and Valium, and now they're resting on their laurels.
-elizabeth
poster:Elizabeth
thread:89603
URL: http://www.dr-bob.org/babble/20020110/msgs/90158.html