Duodopa has been used, quite successfully I understand, for four years now in 12 European countries. The Swedish have perfected the pump system, and the concept of an infusion was tested back in the 80's- this is hardly a new ideal.

From NPF:

Twenty-one years later, the medication called duodopa, administered into an area of the small intestine called the duodenum, is still in clinical trial in the United States.

What is annoying is that it's taken over 20 years for a pharamaceutical company to actually develop this therapy. I suspect it's because pharma didn't think this would compete with oral Sinemet, despite the evidence that a continuous infusion greatly reduces dyskinesia and on/off effects- really it's better for us over all. Now that Solvay sees a market in this treatment, I'm guessing it's the FDA bureaucracy holding things up? Anyone know the story behind this treatment?

Laura

Never mind. Clinical trials once again use the fail proof placebo control; we'll be lucky if duodopa bounces over to MJFF for further research and tinkering before it ends up back on the FDA "fast track"- anyone got another 21 years to spare?

-L

Hey , where did you hear that about the placebo?? I cant imagine it being so. You're getting the drug straight into your system it has to be better!!!!
WTF .. when are we going to get something that will give us some damn help and stop all this marketing ******** if they've had this therapy for 20+ yrs why wont it work for us?
F@@@@ Dumb A@@. Go ahead and censor me

Jim,

Sorry if I confused. It's just that placebo control research is highly suspect any more given the results of the Ceregene trials. They're finding that PWP are highly susceptible to placebo effect (given that it's linked to dopamine centers in brain may have a little something to do with it). I figure that with Duodopa also undergoing placebo controls, there may be problems- this is sarcasm- I don't know that there actually is a problem at this point.

It is true; however, that this therapy was conceived of by pharma researchers over twenty years ago, and that the infusion pump is successful in Europe for at least four years. Why, then, would it be a problem for the FDA to approve it here?

Laura

the university of alabama is doing a duodopa trial with the first four people open label. so the first 4 are getting the drug for sure. the rest is blinded. i don't know if all centers are doing open label and blinded. if not, that would justify the travel to alabama i have been told the first surgery , open label, went very well.. that leaves 3 more open label to go ....at alabama, so ask the other centers if you call about it.

let us know if there are others doing open label will you please?


thank you,
paula

Surely these are known drugs, (Levadopa), why years of research and "blind testing".

God, this situation stinks when we wait years for a different delivery mechanism for a 40 year old drug to be tested.

Why not provide Duodopa to all, today, whats the worst that can happen.

I will attempt to provide an update on UK status following my neuro meeting 11/09.

Neil.

'THOU SHALT NOT APPROVE DRUG iN TRIAL WITHOUT PLACEBO" , sayeth the FDA and most of the other medical profession in the USA.

thanks neil, for letting us know how the real world is doing with this.

paula

I have been in the study since March 2009. I live in Ohio and just wanted to jump in and say that this system really works! I noticed that there seems to be some concern about infection at the port site. I have had little problem with this. A port is a port. Simply keeping the site clean and not snagging your port on something and jerking it are the two most important items. I am now in the second year of treatment. I was not in a blind study. I got the drug from the first. I only have to see my neurologist every six months and life is great.

Dan

My husband is one of two who have participated in the open label trial at Medical College of Geogia in Augusta. He underwent surgery in September, 2009. Had the reported infection at PEG site - very severe. Had to have additional surgery to remove infection and properly place the peg. Duodopa is great. Much less fluctuation and much less dykenisia.

[QUOTE=Conductor71;567959]Duodopa has been used, quite successfully I understand, for four years now in 12 European countries. The Swedish have perfected the pump system, and the concept of an infusion was tested back in the 80's- this is hardly a new ideal.

From NPF:

Twenty-one years later, the medication called duodopa, administered into an area of the small intestine called the duodenum, is still in clinical trial in the United States.

What is annoying is that it's taken over 20 years for a pharamaceutical company to actually develop this therapy. I suspect it's because pharma didn't think this would compete with oral Sinemet, despite the evidence that a continuous infusion greatly reduces dyskinesia and on/off effects- really it's better for us over all. Now that Solvay sees a market in this treatment, I'm guessing it's the FDA bureaucracy holding things up? Anyone know the story behind this treatment?

Laura[/QUOTE

Since the subject came up again, and I didnt see this until now, I will tell you what I know (2 years later) but still might be news. I was invited to a couple of meeings with Solvay executives to discuss their FDA issues which I attended with our FDA consultant Tony DeCamp..This seems to be a case of total misguided heavy handed, mindless regulatory procedure, but I only heard one side. At the first meeting just after they had met with FDA, Solvey's director of R&D was miffed that the FDA would make a rigid requirement for a phase 1 safety test, followed by a phase 2 placebo controlled trial for a treatment where there is such a history and the active ingrdient is sinemet. It was treated as if it was a totally new therapy with no track record. We advised Solvay that it would be difficult to blind Patients from the effects of sinement, and suggested a crossover design that proved to be satifactory for Solvey who was about to pull the plug on the whole project, leaving patients without the option of this therapy,but continued at that time. However I have heard that they did sell out their rights and the placebo controlled trial is still recruiting. chalk one up for rigid regulation.

We think that intellient patient consultants in the meeting withn FDA might make a difference by giving the FDA and the company a way to compromise for the patient's interests, and problem solve on the need for hard data not readily available from therapies approved in Europe.

perry