Parkinson's Disease Tulip


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Old 03-05-2014, 11:43 PM #11
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Originally Posted by Tupelo3 View Post
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.
Thanks for sharing these newer treatments that are on the horizon. This is the first I have heard of the Dopafuse infusion. How exactly is the pump different in its delivery than Duodopa? Is it that one goes through the intestine and the other directly into the bloodstream? It is encouraging that Dopafuse seems to require significantly less ldopa in the system.

The inhaled form has been on the table for a long time. I do think the more direct routes have far more promise than anything oral. The med really needs to bypass our digestive system and maintain steady plasma levels, so I remain skeptical of any oral delivery no matter what the claims are.

I appreciate that there are more promising things in the pipeline; I know that I seem to be looking backward with my enthusiasm, but frankly all of these treatments, including DBS, are far from innovative. Really, they all really are attempts to find more effective and efficient ways of administering ldopa. Given that, I agree with Dilmar, I will take it while we "wait and wait" for better things.

Some of us do not have such a good long term relationship with meds. I went from 300 mg a day of Sinemet to 1200 within 3 years of diagnosis, and not one med adjunct has ever given me substantial "on time". This means I have to dose every nearly every 2 hours. Others have had unsuccessful DBS. To some of us, Duodopa, as clunky and cumbersome as it sounds, would likely help immensely.
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Old 03-06-2014, 02:29 AM #12
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Default Duodopa

My neighbor actually works for Abbvie and is very excited about the results of Duodopa. He is under a non disclosure agreement, so I am not privy to a lot of information, but I do know they are aiming for approval by this summer.
He previously worked for the company that sold apomorphine and said the first thing he was going to do when he gets to heaven is thank God for that drug because it changed the lives of so many people. He said he would see people come in a wheel chair and after the injection, walk out the door like a person who never had PD. The best part is...he says he has seen the same kind of results and feels the same way about Duodopa!
I will talk to him this weekend and ask if there are certain requirements for getting the pump.
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Old 03-06-2014, 09:12 AM #13
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Originally Posted by Lemonlime View Post
My neighbor actually works for Abbvie and is very excited about the results of Duodopa. He is under a non disclosure agreement, so I am not privy to a lot of information, but I do know they are aiming for approval by this summer.
He previously worked for the company that sold apomorphine and said the first thing he was going to do when he gets to heaven is thank God for that drug because it changed the lives of so many people. He said he would see people come in a wheel chair and after the injection, walk out the door like a person who never had PD. The best part is...he says he has seen the same kind of results and feels the same way about Duodopa!
I will talk to him this weekend and ask if there are certain requirements for getting the pump.
there's an apomorphine pump too.
duodopa obviously works, the problem is the cost, complications and complexity, you have to have help with it at times. i've read the accounts where it has given people their lives back.
still have to wonder what affect inhaled levodopa will have on the quality of life of advanced pd'ers if/when it gets approved. also gets around the gastric emptying problem and other problems in the gut that might reduce absoption
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Old 03-06-2014, 10:13 AM #14
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Thanks for sharing these newer treatments that are on the horizon. This is the first I have heard of the Dopafuse infusion. How exactly is the pump different in its delivery than Duodopa? Is it that one goes through the intestine and the other directly into the bloodstream? It is encouraging that Dopafuse seems to require significantly less ldopa in the system.

y.
Actually, Dopafuse is infused subcutaneously using a standard diabetes insulin pump. I saw their CEO give a presentation a few months ago at the Academy of Sciences and the product seemed to have a lot of potential. They are still in Phase II research, which is supported by a MJFF grant.

The drug they are using in the continuous infusion is levodopa ethyl ester (LDEE) which is a prodrug that is rapidly hydrolyzed into levodopa. LDEE has been tested many times in other research and is already FDA approved. Their research so far has shown that the dopafuse infusion provides stable plasma L-dopa concentrations throughout the day. Hopefully, they'll complete the Phase II soon and move on to a more extensive Phase III. Early reported results have shown greater than 60% reductions in off-time in randomized trials.
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Old 03-06-2014, 04:03 PM #15
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"Still have to wonder what affect inhaled levodopa will have on the quality of life of advanced pd'ers if/when it gets approved. also gets around the gastric emptying problem and other problems in the gut that might reduce absoption."

I have a friend who recently trialled this, used as a rescue medication and it had very good effect. Very quick action and lasted well. Guess a concern is the effect of an inhaled substance on the lungs.

Good news indeed about the subcutaneous dopafuse.
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Old 03-11-2014, 07:40 AM #16
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Default NeuroDerm Announces Enrollment in a 2nd Phase 2 Study of ND0612 - Continuous L/C Drug

Another potential alternative.

http://www.digitaljournal.com/pr/1783440
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Old 03-16-2014, 02:58 PM #17
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Default Loosing hope.

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
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Old 03-17-2014, 03:20 PM #18
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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
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Old 03-23-2014, 07:22 PM #19
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Default late stage help duodopa pump

Hi
I posted earlier about this I have a friend 70 year old vet. he is in late stage and in bed.They dont do any therapy for himhe just spends most of his time in bed
he got good benefit from sinemet for several years.I dont know why he never got DBS,maybe the va wouldnt cover it.I think he might get benefit from the pump and get him out of bed.
Id like to find how to get him atleast a trial on this so he can live.
I read that many got mobile again and realy wonder why this is being held up

he lives in upstate ny,any replies are welcome.
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Old 03-23-2014, 09:04 PM #20
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Id like to find how to get him atleast a trial on this so he can live.
I read that many got mobile again and realy wonder why this is being held up

he lives in upstate ny,any replies are welcome.
The US trials have all been completed. The analysis is underway, the paper getting prepared, and then the presentation to the FDA. Supposedly, they're a few months away from filing the NDA. The good news is this drug/procedure does have FDA fast track designation. So, the process will go somewhat faster.

Given that he lives in upstate NY, you may want to look into Canada as an option, where it is already approved. I would imagine insurance could be an issue. In fact, who knows how fast they'll cover in the US.
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