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Re: EMSAM doses too low to effect depression ?

Posted by notfred on June 11, 2006, at 23:54:31

In reply to Re: EMSAM doses too low to effect depression ? » notfred, posted by Jakeman on June 11, 2006, at 22:11:09

> What you are saying is in opposition to the studies conducted my Somerset and others which indicate that transdermal delivery by-passes first-pass metabolism resulting in higher exposure to selegline and less dietary restrictions as well as less exposure to metabolites. How are they wrong?
>


I am not saying they are wrong. They played it safe to get the dietary restrictions removed. There was quite a bit of wrangling with the FDA to get this one on the market. There is limited clinical experience with the transdermal delivery system and avoidance for the "cheese reaction", just a few studies. So they stuck to doses that were already established as safe for Selegline/Deprenyl by mouth. There is quite a bit of clinical experience there.

At the doses of EMSAM indicted to be safe, you could just as well take an equivalent amount by mouth and still not have the "cheese reaction".
The safe doses for EMSAM are in the low part of the range for effective treatment of depression in Selegline/Deprenyl. Unfortunately Somerset did not get approved for higher levels of EMSAM w/o dietary restrictions. But their research does bear out that the delivery system avoids the side effect in question. Higher doses should be OK.
EMSAM's potential is limited unless docs are willing to prescribe higher doses. It would be nice to have a MAOI that is free of dietary restrictions and can be used throughout its therapeutic range.

As to the metabolites, the exclusion of the amphetamines may not be a good thing. They also have MAOI activity and legit use as psyco meds. The levels were really low to begin with. The MAOI's are effective partly because the effect many things, a dirty med, adding a bit of meth/amphetamine may be of benefit.



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URL: http://www.dr-bob.org/babble/20060610/msgs/655784.html