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Will April bring us the long awaited Duodopa?

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Unread 03-16-2013, 02:33 AM   #1
Conductor71
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Default Will April bring us the long awaited Duodopa?

I am not superstitious, so I do not think the following is coincidental:

-In the past year there has been increased chatter on positives of the gel pump in MJFF blog, on the Ask the Doctor forum at National Parkinson Foundation, etc.

-Abbott files for approval with FDA late 2012.

-Notable too is buzz on it in the investor's market.

-Abbott is scheduled to announce on April 25th the results of the Phase III trial at the American Academy of Neurology.

-Abbvie (Abbott spinoff) is the premiere sponsor of the PD Unity Walk on April 27th!!!

This means they are pretty darn sure they have FDA approval. Since Abbvie is a new company with exclusive rights to Duodopa they would have no other PD interest in sponsoring the Unity walk?!?!

I know LFAC has been skeptical over it due to costs and who qualifies. We can relate. However, I would think that since doctors are now on public PD forums recommending the pump as an option for patients who do not want DBS, that they are going to price the pump competitively and not restrict who can have the treatment. In other words, relief!!!

I want to break out and happy dance but want to save it for the official announcement. Am I drawing the wrong conclusions here?!?

I am already dreaming up ways to make schlepping the pump around more attractive and practical.


Laura
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Unread 03-16-2013, 04:54 AM   #2
lindylanka
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Default

Though there was a report about a continuous injection thingy v like the ones for diabetes too, but who knows when it will make an appearance.

For all those waiting for duodopa I hope this is the year it happens, not before time.

Lindy
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Unread 03-16-2013, 08:21 AM   #3
Jim091866
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Default Have you checked the weather?

I'd hate to rain on your parade. I talked to a PR Rep at Abbie Vi, she said that the FDA is reviewing the data and will let them know about marketing approval! That they had not yet submitted for it. Now look back at that statement. The FDA does NOT tell the companies when they can market a drug, they are the ones to submit for approval. This was a ridiculous statement. Anyway all the pharmacuetical journals that I watch do not mention anything to indicate that it's coming anytime soon. Wish it was different.





Quote:
Originally Posted by Conductor71 View Post
I am not superstitious, so I do not think the following is coincidental:

-In the past year there has been increased chatter on positives of the gel pump in MJFF blog, on the Ask the Doctor forum at National Parkinson Foundation, etc.

-Abbott files for approval with FDA late 2012.

-Notable too is buzz on it in the investor's market.

-Abbott is scheduled to announce on April 25th the results of the Phase III trial at the American Academy of Neurology.

-Abbvie (Abbott spinoff) is the premiere sponsor of the PD Unity Walk on April 27th!!!

This means they are pretty darn sure they have FDA approval. Since Abbvie is a new company with exclusive rights to Duodopa they would have no other PD interest in sponsoring the Unity walk?!?!

I know LFAC has been skeptical over it due to costs and who qualifies. We can relate. However, I would think that since doctors are now on public PD forums recommending the pump as an option for patients who do not want DBS, that they are going to price the pump competitively and not restrict who can have the treatment. In other words, relief!!!

I want to break out and happy dance but want to save it for the official announcement. Am I drawing the wrong conclusions here?!?

I am already dreaming up ways to make schlepping the pump around more attractive and practical.


Laura
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Unread 03-16-2013, 11:15 AM   #4
Bob Dawson
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Default got the duodopa rag-time blues

The cost of duodopa appears to be astronomical. Fine. Then say so.

Parkinsons™ belongs to us; duodopa, like sinemet, exists only for Parkinson’s™. So why are we not allowed to know what is going on? Let the FDA declare it legal or not legal, safe or not safe. Then, if the delay is because it costs too much, okay. Just tell us the truth.

It’s our lives you are playing with, by delaying this treatment for years. If it is FDA approved, but the cost – benefit analysis shows that keeping us alive with such an expensive drug gives a paltry ROI (Return On Investment) tell us, so MAYBE we can raise funds and have a PD non-profit organisation go out to tenders in 3 or more European countries to supply this treatment to the U.S.A. – and why not also put out a competitive call for tenders for the guaranteed supply of sinemet for those without duodopa.
Ah, but one Big Pharma outfit has exclusive right to market it, right? So either produce it or get off the pot. Years have gone by, this drug is in daily use in 30 countries…. But we don’t even have the right to know what is going on and why. Is it a health safety delay? A lack of doctors able to do it? Costs too much? Or is it just a corporate strategy, like AMGEN sitting on GDNF for 5 years?

Duodopa has been approved in the following countries, for advanced cases of Parkinson’s™:
Austria, Australia, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Liechtenstein, Luxembourg, The Netherlands, Norway, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland. (U.K.??)
Also approved in Canada “with conditions”, for example a PD Neuro has to swear on a stack of money that the regular swallowing of pills has been tried on you every which way, and this is your last kick at the can.

Some people say Duodopa cost $60,000 per year.

So of course the Canadian on-line “pharmacies” are offering discounts”:
Duodopa Gel 2000/500mg
Source Country: European Union Shipped From: United Kingdom
21 x 100ml Solvay Pharmaceuticals
$3,750.00
But there is no way to know what internet pharmacy you can trust.
The bootlegging on the internet show that it is over-priced.
Let’s get Wal-mart to import for us. (Phantasy)

There may be perfectly good reasons why this treatment has been delayed for years in some countries; while being used daily in other countries.
It would be nice, as we lay dying, to have someone in the Parkinson’s™ Cartel explain to us what is going on. It would be appropriate, given that the whole Parkinson’s™ Industry exists only to serve us and our wretched disease. Tell us the truth.

Hype Alert:
HERE IS THE SALES BROCHURE FOR A PRODUCT YOU CAN’T GET IN THE U.S.A. FOR REASONS UNKNOWN OR UNSAID:
http://www.google.com/url?sa=t&rct=j...43828540,d.b2I
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Unread 03-17-2013, 08:50 AM   #5
Bob Dawson
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Default

Quote:
Originally Posted by Conductor71 View Post
,.,.. I do not think the following is coincidental:

-In the past year there has been increased chatter on positives of the gel pump in MJFF blog, on the Ask the Doctor forum at National Parkinson Foundation, etc.

-Abbott files for approval with FDA late 2012.

-Notable too is buzz on it in the investor's market.

-Abbott is scheduled to announce on April 25th the results of the Phase III trial at the American Academy of Neurology.

-Abbvie (Abbott spinoff) is the premiere sponsor of the PD Unity Walk on April 27th!!!

This means they are pretty darn sure they have FDA approval. Since Abbvie is a new company with exclusive rights to Duodopa they would have no other PD interest in sponsoring the Unity walk?!?!.....

,......I want to break out and happy dance but want to save it for the official announcement. Am I drawing the wrong conclusions here?!?
Laura
Laura, I think you are right - we should be hearing about Duodopa getting FDA approval soon; to be presented officially on April 25 at the American Academy of Neurology, and April 27 they will get a lot of publicity at the PD Unity Walk, to cap off "April is PD Awareness Month." Sounds like a good PR orchestration of events.

If for any reason they do NOT tell us the truth by the end of April, it would behoove the various and multiple Parkinson's charities to state a quasi-unanimous demand that we receive a clear explanation.

This drug has been in daily use in 30 countries for about 7 years. It has not been permitted in the U.S.A. We have a right to know what the hold-up is, or who is being held up. There are people in the FDA and in Pharma and in the stock market and scientists who know all about this, but they are not telling the people the treatment is for: we are just not in their picture, not in their network. Several years have gone by since it was announced that the FDA would fast-track Duodopa. Many were given hope. Then, silence. They figure we can't handle the truth? That's not for them to decide.

By what right do government and business and science collude to keep information from us, the only people the entire project is aimed at? Most of a decade has gone by; half the world has the drug; Americans do not; and no one is told why. And then they expect our co-operation.

Let's put it this way: as Conductor 71 says above:

"-Abbvie (Abbott spinoff) is the premiere sponsor of the PD Unity Walk on April 27th!!!"

If Abbvie does NOT announce anything about Duodopa (good or bad) on or before that date, then I don't see what Unity I would be walking for. Parkies would be a laughing stock, if their premiere sponsor refuses to talk to them about the one and only connection between them. Give their sponsorship money back and have a demonstration march instead.

So Conductor 71 MUST be right - the announcement is coming before the end of April. No other explanation makes sense.

The lack of transparency in the pharma and research world results in a byzantine maze where even simple information is not shared.
SO, Abbott Labs, what's up? You applied to the FDA? Phase III is a hum-dinger? That sales brochure we posted above is what we can fairly expect? OR, you have been delayed, and tell us why, and tell us when. You are playing with human lives; we don't expect miracles, but we do expect the truth; we expect access to information so we can make our own personal decisions about staying alive, if there is a treatment that allows us to function at least part of the time.
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Unread 03-18-2013, 08:25 AM   #6
soccertese
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Default posting from user

http://parkinsonsmovement.healthunlo...-pump?ref=home
from another message board:

Yes. my DH has had the Duodopa pump for over a year. It pumps a continuous dose of Levadopa via a PEG tube inserted through his stomach. The drug is then directed through a tube into his lower intestines where the levadopa is absorbed. My DH got the pump when all medications had proved unsuccessful because of OFF periods and dyskinesia. The pump is cumbersome and needs daily maintenence, however, it does reduce OFFs and dyskinesias dramatically (but not entirely). It is on clinical trials at the moment in the States but has been available in Europe for about 14 years. It is seen as a treatment for advanced PDers and not everyone is suitable.
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Unread 03-18-2013, 10:08 AM   #7
Jim091866
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Default I'm scratching my head here wondering what's going on.

First of all they have NOT to my knowledge submitted request for marketing approval. They stated that they planned to sometime in late 2012.

Second, they DID release the results of the phase 3 clinical trials at the Neurology Conference in New Orleans in April 2012.

Personally, I think we are being held hostage by a therapy that is way too expensive for them to market. Remember, follow the dollars and that will get you to the answer every time. Although they had to know this going into this endeavour so what gives?

Am I reading old news or what?
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Unread 03-18-2013, 01:59 PM   #8
Bob Dawson
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Quote:
Originally Posted by Jim091866 View Post
First of all they have NOT to my knowledge submitted request for marketing approval. They stated that they planned to sometime in late 2012.

Second, they DID release the results of the phase 3 clinical trials at the Neurology Conference in New Orleans in April 2012.

so what gives?

Am I reading old news or what?
Caveman Jim, This is the fast track. You should see the slow track.
If only they would tell the truth.

Back down the rabbit hole. Alice in Wonderland: one pill makes you bigger, the other pill makes you small; but the yellow ones don’t do anything at all… just ask Alice, when she’s ten feet tall…

http://neurotalk.psychcentral.com/thread39476.html

Monday, Feb. 18, 2008
Duodopa...Solvay Receives Fast Track Designation From FDA

Hey, it’s only five years ago. Besides, what’s the rush? Haste makes waste.

…drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review. A Priority Review means that the time it takes the FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.

Year 2008: "We are very pleased that the FDA has granted levodopa/carbidopa intestinal gel Fast Track designation and believe that it will be of great assistance in our efforts to expeditiously bring a new treatment option to this important and underserved advanced-stage patient population," said Laurence Downey, M.D., president and CEO, Solvay Pharmaceuticals, Inc.

Hey Larry, how about an update… you know, we were told it would take 6 months, and now 5 years have gone by…
Oops, sorry Larry. As President of Solvay, you maybe did not foresee this:
Buy this domain
The domain solvaypharmaceuticals-us.com may be for sale by its owner!

Clinical Trials News Digest June 1, 2011
http://clinicaltrialsnewsdigest.com/...or-parkinsons/
Solvay’s Duodopa Intestinal Gel Gets FDA Fast Track Status for Parkinson’s

http://neurotalk.psychcentral.com/sh...d.php?t=151943
Have it on good authority...Duodopa has FDA approval
2011
Paula W said:
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. It’s 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?
__________________
paula
"Time is not neutral for those who have pd or for those who will get it."
http://neurotalk.psychcentral.com/sh...d.php?t=151731

Debi Brooks (Fox Foundation)
Member

06-10-2011, 05:14 PM
Update on Duodopa trial
Yesterday, Abbott Laboratories announced interim data from a long-term, open-label study treating advanced PD patients with levodopa-carbidopa intestinal gel…

The study will be presented on April 25 as part of the Emerging Science program (formerly known as Late-Breaking Science) at the American Academy of Neurology’s 64th Annual Meeting in New Orleans April 21 to April 28, 2012.

From FDA website:
Import Refusal Report
• FDA

Refusal Details as Recorded in OASIS by FDA
for Refusal 336-6232878-4/5/1
Import Refusal Report

Manufacturer FEI 3008853777
Manufacturer Name Egis Hungary
Manufacturer Address line 1 1475, 10
Manufacturer Address line 2
Manufacturer's City Budapest
Manufacturer Province/State
Manufacturer Country/Area Hungary
Product Code 62JIY09
Importer's Product Description DUODOPA (LEVODOPA-CARBIDOPA) INTESTINAL GEL FOR CLINICAL TRIALS
Refusal Date 06-Feb-2012
FDA District CHI-DO
Entry/doc/line/sfx 336-6232878-4/5/1
FDA Sample Analysis No
FDA Record of Private Lab Sample Analysis No
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS 502(f)(1), 801(a)(3); MISBRANDING The article appears to lack adequate directions for use.
Refusal Details as Recorded in OASIS by FDA
for Refusal 336-6232878-4/5/1


Ahhh yes misbranding. no instructions...... for a clinical trial
scientists just did not know what to do with it right fda??"?????
Misbranding ! Hahahaha.
we are dying out here and these jerks are jerking
Happy Unity parade
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Unread 03-18-2013, 02:32 PM   #9
Jim091866
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Default We've been treating the wrong disease!

All you have to do is substitute an "E" for the "P" in PD and we'll have approval!
Just imagine reduction in off time of an average of 4 hours. More "on" time, oh yeah! Bob tell me we wouldn't see a record Fast track there!

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Unread 03-19-2013, 07:33 PM   #10
Jim091866
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Default Bump

Bumping it up



Quote:
Originally Posted by Jim091866 View Post
All you have to do is substitute an "E" for the "P" in PD and we'll have approval!
Just imagine reduction in off time of an average of 4 hours. More "on" time, oh yeah! Bob tell me we wouldn't see a record Fast track there!

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