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Monthly cost, oral vs. EMSAM, efficacy

Posted by psychobot5000 on December 7, 2006, at 21:45:35

In reply to Re: Cost of oral selegiline linkadge, posted by laima on December 6, 2006, at 17:46:46

" I suspect much of Emsam's cost is to pay for all of their years of research and tweaking, because, of all things, it was rejected at least once by the FDA for being ineffective."
___
I don't understand why it's so expensive, but I feel I should mention that EMSAM was never rejected because of efficacy--as I understand it, the concerns were over the labeling guidelines concerning the dietary restrictions. When they eventually got enough data on it, the FDA and the manufacturers settled on the issue, and it was released, with the manufacturers successfully convincing the FDA to drop the dietary recommendations at the 6mg dose, but not 9 and 12.

That said, since this group is largely treatment-resistant depressives of varying sorts, efficacy is frequently going to be a problem. As for cost, from what I remember, the cost of 5mg/day of oral selegiline runs about 30$/month, assuming you are uninsured. However, a doc who had done research in this area told me 'oral selegiline does not become an effective AD until 30mg.' While 30mg or even 65mg of oral selegiline might be an effective AD, though, it is not in practice exactly the same drug as EMSAM, because of amphetamine and other metabolites exerting other psychopharmacological effects, and thus changing the picture.

As for the difference between the oral version and EMSAM, it runs like this as far as I understand it: The transdermal patch allows for 74% bioavailability, meaning (as I understand it) it's in the blood and active. It's steadily absorbed over the whole 24 hour cycle, so no peaks or lows. You get a much higher concentration of the parent drug in the bloodstream than is possible with the oral version, which has a (according to studies) 4.4% bioavailability. When you digest the pills in your gut, the vein carrying the drug into the bloodstream leads into liver first, meaning that most of the drug is processed into metabolites, and (as I understand it) it's just that 4 or 5% that's left. The metabolites include several isomers of amphetamine, meaning you may (theoretically) feel more energized with the oral selegiline, but may have more trouble sleeping and have other such s/e, etc etc. Also, the pill is digested within an hour or two, and the blood levels spike and then disappear as the drug is eliminated. Because EMSAM doesn't undergo this 'first pass metabolism,' before getting to you, the balance of the parent drug to the amphetamine metabolites is much higher, which could be good or bad, I suppose, depending on what you are after.

Oral selegiline is an effective AD, but not as effective as EMSAM (as I understand it), because you'd have to take so much more to get the same effective levels in your blood. If you did, you'd have high levels of stimulant amphetamines in your bloodstream, too.

From what I understand, EMSAM is also a rather different drug at 9mg and 12mg than at 6. Some patients need the 9mg patch to begin feeling substantial benefit, from what I have read.

I can't vouch for this being completely accurate, because I don't understand all of the background necessary, but I feel confident that my sources are good.

P-bot

> > What is the cost of oral selegiline?
> >
> > Say...a month at 5mg ?
> >
> > Linkadge
>
>


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URL: http://www.dr-bob.org/babble/20061206/msgs/711307.html