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 believe that the US trials are close to completion. The research teams had asked for several extensions. I know for a fact that there have been several issues, such as insertion site infections and tube displacements. I doubt this will ever become a mainstay product. There are other drugs and devices currently being tested that appear to be simpler, safer, and better.

Nevertheless, this is another example of the time delay in the US for getting drugs/products approved. Remember, DatScan received European approval almost 10 years prior to US approval.

I emailed Abbvie last night and received a phone call from them about an hour ago. That in itself was quite a surprise.

They have submitted a request for review with the FDA and expect to know if it will be approved within the first half of this year!!! Finally! It is now just a matter of months...

I asked about cost and was told that would be determined if/when the FDA approves it. Sorry nothing more specific; regardless, this is really good news.

Laura

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.

Thanks for the update Laura.

I absolutely agree that everyone should have an option. It's inexcusable that this process should take so many years in the US. However, I do think that the combination of cost, complications and inconvenience will limit the ultimate market for the product.

SynAgile is in Phase II for their DopaFuse subcutaneous infusion pump. So far the results have been very promising. They are using a standard, off-the-shelf, diabetes infusion pump for continuous L-Dopa delivery. There are the possibilities for extended release dopamine (if only Impax could get their act together) and other drugs to enhance half-life, like Intec Pharma's Accordion Pill, which decreased "off-time" significantly in Phase II trials. There are several inhalable versions of dopamine being researched. I just think that over the next few years there will be simpler and equally effective alternatives to the duodopa pump.

As I understand it, the benefits of Duodopa come from the ability to reduce plasma variability of levodopa, rather than from any chemical differences. [1] states:
"1 ml [of Duodopa] contains 20 mg levodopa and 5 mg carbidopa monohydrate"

The issue here is can we make better use of present medications. Do we take into account the effects of diet (protein intake especially) and gastric emptying rates? Do we know the effect of reducing the time between oral doses?

There is also the possibility that some of the apparent marginal (as compared to standard levodopa preparations) benefit comes from an increased total daily dose. An indication of the doses involved is given by [1].

"The average recommended daily dose of Duodopa is 100 ml, containing 2 g levodopa and 0.5 g carbidopa".

Note: that's 2g = 2000mg

The issue here is would many people with advanced Parkinson's benefit from increased doses of levodopa?

References

[1] eMC
http://www.medicines.org.uk/emcmobil...cine/20786/spc

John

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.