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Old 07-30-2015, 02:32 PM #1
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Default DopaFuse

http://www.synagile.com/ . As reported here before, SynAgile is developing DopaFuse for continuous l-dopa administration. MJFF says it is subcutaneous, but the company says it is an oral appliance that leaks small amounts (3 ml daily) of a prodrug into the saliva to be swallowed. They say it is comfortable, not visible, and it doesn't interfere with speech or swallowing.

They say that they are finished with phase 2a. Does anyone know when phase 3 begins? Also, I wonder whether you can eat while it is in the mouth, and whether food interferes with its effects. It sounds promising.
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Old 07-30-2015, 05:02 PM #2
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https://www.google.com/url?sa=t&rct=...99028883,d.eXY

http://www.faqs.org/patents/app/20140088192

Anybody have a link to the study?
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Old 07-31-2015, 12:40 PM #3
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Quote:
Originally Posted by GerryW View Post
http://www.synagile.com/ . As reported here before, SynAgile is developing DopaFuse for continuous l-dopa administration. MJFF says it is subcutaneous, but the company says it is an oral appliance that leaks small amounts (3 ml daily) of a prodrug into the saliva to be swallowed. They say it is comfortable, not visible, and it doesn't interfere with speech or swallowing.

They say that they are finished with phase 2a. Does anyone know when phase 3 begins? Also, I wonder whether you can eat while it is in the mouth, and whether food interferes with its effects. It sounds promising.
Gerry, I've been in contact with Ephraim Heller, the company's CEO. SynAgile was working on a subcutaneous delivery, as reported by MJFF (who helped fund the trial). They have subsequently switched their delivery model. I'm not sure why, but, if I had to guess, I would think it's because Neuroderm is so far ahead of them in that design process along with being well funded as a public company.

SynAgile is now working on a levodopa/carbidopa delivery device in the form of a small retainer that resides in the mouth. The device continuously infuses levodopa/carbidopa into the mouth. They have recently completed patient treatment in a small proof of principle clinical trial looking at whether continuous levodopa carbidopa delivery into the mouth stabilizes the concentration of levodopa in the blood and leads to reduced Off time. The results of the study should be available in August and the company intends to issue a press release in the coming months and publish the results in a peer-reviewed scientific journal. They are now trying to raise the funds required to complete product development and run a clinical trial of the entire system. There is no clinical trial going on at this time.

Gary
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Old 07-31-2015, 05:45 PM #4
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Default how is this absorbed?

Sounds interesting, but how does the body actually get the ldopa when it's in a retainer in the mouth? Does it get absorbed before you swallow, or after... because if after, that is just another delivery method into the gut which we all know what happens down there with food interference, etc. But if it is absorbed while in the mouth, through the skin there, that would by-pass the gut and those related issues, and that could be really helpful.
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Old 08-01-2015, 08:25 AM #5
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Quote:
Originally Posted by lurkingforacure View Post
Sounds interesting, but how does the body actually get the ldopa when it's in a retainer in the mouth? Does it get absorbed before you swallow, or after... because if after, that is just another delivery method into the gut which we all know what happens down there with food interference, etc. But if it is absorbed while in the mouth, through the skin there, that would by-pass the gut and those related issues, and that could be really helpful.
I'm pretty sure this formulation is absorbed in the small intestine so you'll still have digestive system interference - slow gastric emptying, constipation slowing down the movement of material in the intestine, protein interference. if a form of l-dopa could be absorbed sublingually i doubt we'd be messing around with developing inhaled l-dopa and sublingual apomorphine as rescue drugs.
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Old 08-01-2015, 11:07 AM #6
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I'm pretty sure this formulation is absorbed in the small intestine so you'll still have digestive system interference - slow gastric emptying, constipation slowing down the movement of material in the intestine, protein interference. if a form of l-dopa could be absorbed sublingually i doubt we'd be messing around with developing inhaled l-dopa and sublingual apomorphine as rescue drugs.
ST, you're absolutely right, the L/C formulation is absorbed in the gastrointestinal track the same way regular L/C and is likely to be subject to all of the same issues. The new science here is with the device, which provides an ongoing continuous flow of L/C into the digestive system via saliva.
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