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

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

Hi,
I hope this drug delivery system system is soon approved. My wife is running out of time and is close to entering a nursing home. She has a very hard time remembering to take her pills (every 2 hours), she has hallucinations, is down to 100 lbs and is in a very fragile state. Her neurologist has just ruled out DBS because of hallucinations. It's all beginning to sink in that there's not much more that can be done and her life is going to change.
John

John,
Your wife, do you think it could be med related, the hallucinations?
Perhaps discuss the lowering or cessation of agonists or other likely causes with neurologist.
Is she underweight due to dyskinesia?
If so a discussion re meds and cause of why she's so thin.
Is she elderly or unable to communicate her needs?
Perhaps a consultation or chat with her and family to know you've exhausted those and any other questions you might have.
The pump may if she is In a poor state be her saviour.
Best wishes