[QUOTE=Perryc;743035]
Quote:
Originally Posted by Conductor71
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
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Laura here. Hugs to you for finding this and reporting...this is indeed news! Paula has been inquiring on this also and we have Jim who is ready to establish residency in Europe for treatment. I say that I have to agree with R& D at Solvay it is an absolute outrage that the FDA is treating them as if this were a new drug and I hope I can say I wonder where Medtronic fits into the picture. I have only been diagnosed for three years, age 43 with a 2 year old boy, and all I hear every six months is how I do not show any sign of Parkinsonism on Sinemet but to prepare myself for DBS in a year or two!?!? I may appear normal but have to dose every two hours to keep it that way, and frankly some days my MDS makes a lot of sense with his mantra. Clearly there is a huge market for a less invasive alternative.
I am very near starting an electronic petition here in the states and an information campaign. Sanjay Gupta and MJF should be discussing this on CNN. Where is the focus on the needs of more advanced patients in the here and now? This is so unbelievable to me. Anyway, I am on the verge of civil disobedience, but if there is any way I can become directly involved in promoting Solvay's efforts, please PM me. Also, who might I contact at Solvay for their perseverance and willingness to even attempt establishing a market here and giving us a much needed alternative- suppose I could just track down someone on web site but it is so much better to reach the right person.
Laura