Trampy
(Pooh-Bah)
09/01/03 08:54 AM
Re: " No Ultram For You...!!!???"

Quote:

(I can look up where I read the information from anti-depressant to pain killer -- it was about 6 or so months ago that I saw it). Corrie




Yes, please look it up for us. I've never seen any mention of tramadol being marketed as an antidepressant ... but i don't follow the German pharmaceutical news. McNeil (?) has the U.S. patent on using it for pain. A patent for depression would be a different patent. If it was patented in Germany before 1977, then the German patent has expired and so it would be considered an orphan drug here for use on depression because the U.S. respects German patents and so it would not be patentable here.

But if it WAS patented and marketed in Germany for pain, then McNeil would be able to mention that in the full product insert for doctors ... thereby suggesting that off-label use (since it never underwent FDA depression trials, it'd be an off-label use even though we respect German patents).

Bottom line. If this is true, i'd guess that doctors here would be prescribing it for depression and the manufacturer would be able to tell them about it. That'd be a lot more than what they use to sell Neurontin for all its off-label indications (that is, the successor to P-D, not McNeil) .. which is stretching the limits.

Sorry for going on so long, but being marketed in Germany for an indication would carry a lot more weight with the FDA than what made Neurontin a blockbuster ($2 B/yr) drug.

Tramadol increases serotonin levels, but it's not an SSRI ... and they don't know how it works. (But they don't know how a lot of drugs work for the FDA to approve the use.) Any FDA-legal use of a pain drug for depression would set a big precedent that would be great, in my opinion. Off-label use is legal and tramadol is not even scheduled, so doctors would not need to worry about being charged with illegal distribution. Some doctors were doing it with buprenorphine, and a few brave doctors have done studies on using strong opiates as ADs, but that's small potatoes compared to what would happen if the manufacturer of Ultram could list depression in their product insert. For that reason, i doubt it was marketed in Germany as an AD. Please prove me wrong.

Trampy



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