I wrote a letter outlining Duodopa, and the way the medication works. I also stressed that this treatment is available now, except to those of us in the U.S. We'll see what comes of it but at least I spoke my peace. I challenged the "effectiveness" of the FDA with their bureacracy of an approval process as well. Sent copies to my state senator and to the President. As the President once said "who's butt do I have to kick?

If the FDA has serious worries about this, they should explain the reasons to us, and explain what the difference between their evaluation of Duadopa and the evaluations done in Europe. We have this disease; it is OUR disease; we have some sort of right to know what is going on. Treat us like adults and have a discussion. Maybe the FDA is right to keep Duadopa away from us. But when there are no answers to our questions, we can't help but speculate - for example, is the real problem not medical but financial? Apparently for some reason this treatment costs an incredible amount of money. But would the FDA make a decision based on cost? Or have they discovered a flaw in the treatment? Or they just did not get around to looking at it because we are a low priority?
Much better if they would both listen to us and speak to us. As it is, Americans keep turning up in Europe for the treatment, to the extent that Europeans have a word for it - "neuro-tourists".

Bob, Surely someone from MJFF must have knowledge about the non processing of Duodopa by the FDA. Anyone from MJFF on here that can shed some insight into this question? thanks, madelyn

http://www.touchbriefings.com/pdf/3009/Mouradian.pdf

Where to Infuse
Levodopa is poorly soluble in water, making it impractical for outpatient
or ambulatory use. Furthermore, it is irritating to veins and soft tissues,
ruling out long-term intravenous or subcutaneous administration. The
current solution is the gel formulation, used in Duodopa, which reduces
the volume of infusate 10-fold, and as it includes carbidopa eliminates
the need to take additional oral medications. By delivering straight to the
duodenum, Duodopa also avoids the problems of erratic gastric emptying
and interference from food boluses.
Conclusion
After more than two decades of research into continuous dopaminergic
stimulation, the original data have stood the test of time and the hypotheses
are still valid – it is the intermittent method of administration of levodopa,
coupled with the underlying neural degeneration, that causes motor
fluctuations and dyskinesias. More data are generated each year that further
support these hypotheses. In parallel, there have been significant advances
in developing both a workable formulation of levodopa for infusion and a
practical way to deliver it continuously, thus reducing or even eliminating the
off periods and improving patients’ quality of life.

[QUOTE=soccertese;
... thus reducing or even eliminating the
off periods and improving patients’ quality of life.[/QUOTE]

Say that one more time:
...thus reducing or even eliminating the
off periods and improving patients’ quality of life.



... even eliminate off periods,,, that would be quite acceptable if they could do that. in fact, eliminating off period would pretty much be all I would ask for right now

Between the FDA's ridiculously obstructionist policy about this medication and the drug makers extreme cost, almost $1,000 a week for the medication, this will never see the light of day. Anyone remember the Amgen fiasco, and Abbott has not even sought approval. To my knowledge the phase 3 trials are out with results reported at a conference in April 2012 in New Orleans the company was said to looking towards seeking marketing approval sometime towards the end of 2012. I think it is also affected by this new healthcare legislation. Oh, lest I forget, this drug was developed from something that was on the orphaned drug list, compiled from stuff that was alreadyB approved but on the shelf! Shheeez!!!! And we're searching for a cure??!!!

PUUUUULEASEwe haven't cured anything since polio! We've got this disease for life!!! With or without big pharma. They don't want to cure it, just keep 'em going for another day. Oh, and it's time to take another pill.

THAT my friends is the truth of the matter!