Quote:
Originally Posted by Conductor71
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.