Have it on good authority...Duodopa has FDA approval
 

Hi All,

This is a rather incredulous story. My hair stylist's mother has advanced PD and she has another client besides me with it. This man was in the middle of DBS and made the surgeons take everything out because he was in so much dystonic pain from being off meds. The doctors did as he asked. His doctor left the room and came back to tell him that he was in luck. Duodopa had just been approved!!! Better yet, he could have the surgery done in July!!! Like as in a month from now, not next year, or five years. Seems doctors have had equipment ready to go just waiting for Abbott results?

Too good to be true?! I am usually pretty skeptical of this sort of hearsay, but the doctor spreading the news is my former MDS Dr. Lewitt who designs clinical trials himself and who most recently was involved with Neurologix in the GABA trials, so he would have access to "insider" info.

Anyone else hear any such news?


Laura

well it needs to be-finally
 

that's good and i hate to rain on the parade but is it covered by insurance? it's out of our price range.

we need to start checking into this. it will hold it up. its up to patients to be loud about this.


with stalevo at 800 + dollars a bottle you can imagine how much this is going to be monthly.

damn greedy people - the world is a big corrupt place that is on a slippery slide . a good person would not make people fight for the coverage, are there any good people to influence this coverage?

So what's the deal?
 

Maybe if this doctor is someone you know you could ask him about this. I suspect the guy misheard them to say something like he is going to be included in the trial. I have looked all over for this, as I have been following closely because I am not eligible-I had DBS. I cannot find anything except that the company- Abbott labs has plans to conclude complete the current trial around the end of 2012 then evaluate where it will go from there.

Thinking the same....
 

The odd thing is there are no Duodopa trials in our area. At first I thought it was the GAD treatment via viral vector as he is involved in that but he cannot manipulate who gets placebo. Plus they are way behind in phase studies predicated on funding for phase III.

As for Abbott and Duodopa, the FDA fast tracked it in 2008, so four years later and they'r still jumping through hoops? My thoughts were that the FDA
were willing to consider the 12 week data all things considered.

I can e-mail his office today and hopefully get a confirmation or correct the info here.