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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 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.
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.
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? 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. 4 months is not long. I'm encouraged.
I've read that selegeline enhances sex drive and also that it causes sexual dysfunction. Which is it?
Thanks
Posted by OldSchool on January 10, 2002, at 18:00:07
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.
>
> 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.
>
> 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? 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. 4 months is not long. I'm encouraged.
>
> I've read that selegeline enhances sex drive and also that it causes sexual dysfunction. Which is it?
>
> ThanksHere is my personal prediction. I predict the MAOI patch WONT be FDA approved. Im skeptical it will get to the drugstore anytime soon. Maybe thats just my depression talking. I predict it will be blocked by the FDA, possibly from political lobbying by other pharmaceutical companies. Because a Selegiline MAOI patch would be big competition for the SSRIs. The SSRIs are big money makers and nobody wants to screw with that. This is one of the main reasons RIMA MAOIs are not marketed in the USA...competition with the SSRIs.
Id love to see this MAOI patch come to market, but Im skeptical it ever will.
Old School
Posted by spike4848 on January 12, 2002, at 21:02:09
In reply to Re: Selegiline Patch FDA Update, posted by OldSchool on January 10, 2002, at 18:00:07
This is one of the main reasons RIMA MAOIs are not marketed in the USA...competition with the SSRIs.
>
> Id love to see this MAOI patch come to market, but Im skeptical it ever will.
>
> Old SchoolHey Old School,
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?
Spike
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
Posted by MARKED on March 20, 2004, at 14:57:17
In reply to Re: Selegiline Patch FDA Update - Tom, Spike, posted by Elizabeth on January 14, 2002, at 19:15:16
Quite true, with all the pharmaceutical companies competition and the high cost of FDA approval, ROCHE has declined to initiate the process in North America. It is available in Canada, Europe, Australia and the Net. I was on it for up to 2 years (and on/off for 4 years). It is definately recommended by me, and I believe with a SSRI or the original (taken off shelves with no reason -Brofaromine (which was this very type of combination)it would have been a good combination). Funny enough, the pharmeceutical companies are working on many of these types of dual combined medications to this day, it's all money & politics. They are using old drugs and renaming most of them with slight differences in their chemical structures with other well known antidepressant medications, to create a combined acting drug with minimal side-effects.
----MARKED
> 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
This is the end of the thread.
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