I wonder why this wonderful device has not been approved in the USA .

It is avalable now in Canada and many other countries.

Thanks

john

I dont' know either, but will say this:

1. our former neuro thought it was a horrible idea to let the patient be in charge of the button that dispensed fast ldopa....

2. we thought this odd, since the patient is already in charge of how much ldopa they get-most neuros give patients quite a bit of leeway (for example, the script might be for 8 sinemet a day but you usually only need six, but can take 8 if you need it that day, etc.)

3. ...until we read reviews of folks in Europe who'd gotten it...almost all of the patients were using way more drug than before, typically 40% more! I think most PWP would feel a lot better too if they were walking around with 40% more ldopa in their system.

So now we understand the concern of our former neuro...also it's major surgery and you have a tube sticking out of you that needs to be kept sanitary, etc. There are downsides.

And, of course, probably what is the real reason: the ldopa gel is horribly expensive and only the wealthy will be able to afford this treatment, it'll run over 100K/year....unless covered by insurance, which gets us to why this hasn't been approved yet in the USA for PD....no insurer wants to have to cover it.

No doubt some people do use more than prescribed but I dont think that should be such a concern to stop its introduction. its been around a while now. Long enough for all these countries to approve it. (From EPDA site)

......all 30 countries of the European Economic Area (EEA = EU plus Norway, Iceland and Liechtenstein), Croatia, Switzerland, Canada and Australia.

Austria
Australia
Belgium
Bulgaria
Croatia
Czech Republic
Denmark
Finland
France
Germany
Greece
Hungary
Ireland
Israel
Italy
Luxembourg
The Netherlands
Norway
Romania
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom

I agree that the major downside is being tethered to a tube, but it can be removed for bathing and swimming. There are risks with any surgical treatment but given the choice I would opt for this over risky, highly invasive brain surgery that may or may not work. I have a friend with PD who happens to be an MD, and she will not have DBS because in looking at risk stats she finds the stake are too high. My neurologist has acknowledged "the risks are high, but so is the potential for a big payoff." The thing is Dudopa optimizes Gold standard med without months of tweaking, infection in your brain, risk of speech damage, no promise of less dyskinesia, or no promise that it in some ways leave a patient worse. We know that Duodopa works in over 90% of cases.

I think we should have the option, at least. I have heard nothing but positive results from participants in the Duodopa trials; many saying they have their lives back. That is enough to convince me.

Here is a link to a blog post by a patient advocate who was a professional musician until PD took over her life. She has had PD for 18 years and is now not only playing sax again but is performing on tour thanks to Duodopa. She is getting the word out for Abbvie that the pump works. Normally, I would scoff at that sort of exploitation, but if it gets the word out that can only work in our favor by increasing demand and potentially lowering costs. I can only hope...

http://www.temple-music.com/on-the-road-again/

I am glad this is working for some, but wonder just how many will be able to get it here. I have read reports, albeit anecdotal, that you cannot get this in the UK unless you are literally unable to function with oral meds....in other words, it's a last resort and allowed only when the costs for helpers and aides on top of your meds and therapies and nursing home/facility fees are less than what duodopa would be. One person wrote that only those that did not have long to live were allowed to get it.

I don't know what restrictions other countries have put on duodopa.

Hopefully my pessimism is misplaced and once approved, this will be widely available to all PWP in the US.

http://www.temple-music.com/on-the-road-again/[/QUOTE]

Thanks for the link Laura. Last time I heard Barbara was on Apomorph so interested she has changed to Duodopa. There are also the videos of Pers from Sweden which I am sure have been posted here before.

Lurkingforacure I no longer live in the UK, but i do not think this is a treatment for those who may be near needing nursing home care but more likely people like Barbara. The guidelines used (NICE guidelines) for assessment are on the web. Whether the funding is available in your area is a fraught topic.

This debate of 2007 considers whether duodopa should be offered before DBS.
http://www.acnr.co.uk/JA08/ACNRJA08_duodopa.pdf

I too look forward to other less invasive options but I'd like to have this option while we wait and wait.

Thanks for sharing these newer treatments that are on the horizon. This is the first I have heard of the Dopafuse infusion. How exactly is the pump different in its delivery than Duodopa? Is it that one goes through the intestine and the other directly into the bloodstream? It is encouraging that Dopafuse seems to require significantly less ldopa in the system.

The inhaled form has been on the table for a long time. I do think the more direct routes have far more promise than anything oral. The med really needs to bypass our digestive system and maintain steady plasma levels, so I remain skeptical of any oral delivery no matter what the claims are.

I appreciate that there are more promising things in the pipeline; I know that I seem to be looking backward with my enthusiasm, but frankly all of these treatments, including DBS, are far from innovative. Really, they all really are attempts to find more effective and efficient ways of administering ldopa. Given that, I agree with Dilmar, I will take it while we "wait and wait" for better things.

Some of us do not have such a good long term relationship with meds. I went from 300 mg a day of Sinemet to 1200 within 3 years of diagnosis, and not one med adjunct has ever given me substantial "on time". This means I have to dose every nearly every 2 hours. Others have had unsuccessful DBS. To some of us, Duodopa, as clunky and cumbersome as it sounds, would likely help immensely.

My neighbor actually works for Abbvie and is very excited about the results of Duodopa. He is under a non disclosure agreement, so I am not privy to a lot of information, but I do know they are aiming for approval by this summer.
He previously worked for the company that sold apomorphine and said the first thing he was going to do when he gets to heaven is thank God for that drug because it changed the lives of so many people. He said he would see people come in a wheel chair and after the injection, walk out the door like a person who never had PD. The best part is...he says he has seen the same kind of results and feels the same way about Duodopa!
I will talk to him this weekend and ask if there are certain requirements for getting the pump.

Actually, Dopafuse is infused subcutaneously using a standard diabetes insulin pump. I saw their CEO give a presentation a few months ago at the Academy of Sciences and the product seemed to have a lot of potential. They are still in Phase II research, which is supported by a MJFF grant.

The drug they are using in the continuous infusion is levodopa ethyl ester (LDEE) which is a prodrug that is rapidly hydrolyzed into levodopa. LDEE has been tested many times in other research and is already FDA approved. Their research so far has shown that the dopafuse infusion provides stable plasma L-dopa concentrations throughout the day. Hopefully, they'll complete the Phase II soon and move on to a more extensive Phase III. Early reported results have shown greater than 60% reductions in off-time in randomized trials.

Hi
I posted earlier about this I have a friend 70 year old vet. he is in late stage and in bed.They dont do any therapy for himhe just spends most of his time in bed
he got good benefit from sinemet for several years.I dont know why he never got DBS,maybe the va wouldnt cover it.I think he might get benefit from the pump and get him out of bed.
Id like to find how to get him atleast a trial on this so he can live.
I read that many got mobile again and realy wonder why this is being held up

he lives in upstate ny,any replies are welcome.