[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