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I've been scratching my head over a pharmaceutical question regarinding Vayarin and Vayacog for a while, but I finally thought that it might be productive to ask this brainy group about them.
I've seen these products pop up in a couple of offices (pamphlets, drug reps, etc.). I had previously heard of phosphotidylserine being used as a supplement for various cognitive issue (Alzheimer's, ADD), but this is a prescription product that somehow combines phosphotidylserine with DHA and EPA.
The company that sells this says that the compound in its products is called Lipicogen (in the case of Vayacog) or Lipirinen (in the case of Vayarin). I've written to the company to get more info to see how this is really different from a combination of phosphotidylserine and EPA/DHA you would consume from foods (meats, fish, beans) or supplements, and I haven't gotten a clear answer.
A doctor I spoke to who prescribes these (a friend, not someone who is involved in any treatment) said that Vayarin and Vayacog can cross the brain-blood barrier but that fish oil and phosphotidylserine cannot, which I found fishy.
Here is my correspondence with the company. If you can help me make sense of this, I would greatly appreciate it!
First e-mail
To [Redacted]:
My main question is whether the ingredients in Vayarin co-exist (like a cocktail drug) or are they somehow synthesized together? In other words, is there any difference in taking the contents of Vayarin separately than taking Vayarin?
I was told by a doctor that the ingredients are in fact somehow fused together rather than simply co-existing as a cocktail supplement, but she didn't know the mechanism of this. She said that your products crosses the blood/brain barrier while over the counter supplements do not. I'm not sure how this could be true as fish oil has been shown to be somewhat effective in treating depression, indicating its chemical components likely cross the blood-brain barrier. The doctor I spoke to had received her information from Vayarin representatives; is this also the position of Vaya Pharma?
Thank you for your time and your information,
[Redacted]
Response:
Dear [Redacted]
Thank you for contacting VAYA Pharma.
I will try and answer all of your concerns.
Vayarin® is a Medical Foods and its efficacy and safety for the dietary management of ADHD were shown in repeated double blind placebo controlled trials, all published in peer reviewed journals.
Attached please find the package inserts, where you can find a short summary and a partial list of the relevant publications.
You will note that PS can potentially interact with some anticholinergic and cholinergic medications and that this is for a physician to address that properly.
The Vayarin® PS-Omega3 molecule is a single molecule rather than a mix and that's the uniqueness of it; the Omega3 fatty acids are chemically bonded to the phospholipid (in this case, the PS). As per superiority to fish oil, we have shown in a pre-clinical trial (also published in peer reviewed journal) that the DHA availability to the brain following oral consumption is superior with the PS-Omega3. This was in comparison to fish oil and to fish oil mixed with soy derived PS. Yes, the fish oil did gain some improvement but not as distinct as our molecule. I'm not sure how familiar you are with the terms but I will say that only the PS-Omega3 molecule achieved statistically significant change (improvement) with compare to the placebo arm.
I wish to add that the Vayarin® molecule is present in breast milk. I cannot state the reason for that but it does present an indication to its safely and some will say necessity as well.
As for prescribing off label, this is entirely in the hands of the physician and I cannot comment on that – good or bad. Generally speaking, to the best of my knowledge, it is a common practice and MDs do that when looking for alternatives, based on their educated knowledge and experience.
Do visit our website for additional information: http://vayarin.com/
Feel free to contact me with any future questions.
Kind regards,
[Redacted]
Second e-mail (never received a response):
Dear [Redacted],
Thank you very much for your response, but I still can't quite put together what Vayarin is.
You explained that the difference is that Vayarin is a single molecule. You must understand I only have a high-school education, and so I am trying to understand this with limited scientific background. What confuses me is that Vayarin is a medical food, but somehow its different components have been synthesized into one molecule. Is that common with food? For example, if you were making a salsa, do the tomatoes and onions combine to form a new molecule? I had always assumed not, but I don't know the answer with absoluteness.
I tried looking at the prescribing information which confused me more.
It says that each Vayarin tablet contains 167 mg Lipirinen, which I assumed was this molecule that is formed from combining EPA, DHA, and phosphatidylserine. But then it goes onto list that each tablet contains a certain number of milligrams of each ingredient. How can it list milligrams of each constituent if those constituents no longer exist in their original forms and combined into one molecule?
So, I looked at the ingredients to further try to figure things out. It lists:
Phosphatidylserine, Hypromellose, Silicon Dioxide, Rosemary Extract (preservative), Mixed Tocopherols (E306-E309), Ascorbyl Palmitate (E304), Titanium Dioxide (color), FD&C Blue #1 (color).
Again, excuse my likely overlooking something, but I don't see any ingredient that would provide EPA or DHA. Below the ingredients, the prescribing information says the product contains krill. But none of those ingredients look like krill.
Finally, there is a drawing of the chemical structure of Vayarin. I finally thought: this will show how it is one molecule. But then I see that there is an asterisk next to Chemical Structure, qualifying that the diagram is a "Schematic structure of one of the most abundant molecules present in Vayarin®."
Which molecule? Is this common in medicine? I would assume that its the molecule of the active ingredient that would be given a diagram, but this could just as easily be a diagram of the silicon dioxide.
I am still just trying to figure out what Vayarin and/or Lipirinen are (if there are any differences between the two).
Is it a dietary supplement that contains phosphatidylserine along with omega-3 oils? I know that you said it isn't, but I still don't see how it's a bonded molecule.
Sincerely,
[Redacted]
Any thoughts on whether this product is really something different than the sum of its parts?
Link to the company:
http://vayapharma.com/selectSystem/default.aspx
Here's the WIkipedia link - it gives a good overview of their claims, as it sounds like it was written by the company:
http://en.wikipedia.org/wiki/Vayarin
Addendum:
Just googling around and come across quite a few threads of parents saying how much Vayarin has helped their children. They all seem to say it makes a difference at the 2 month mark (interesting, as I'm surprised most would be willing to wait it out that long).
Here's one such thread:
http://www.mothering.com/community/...rin-or-phosphatidylserine-dha-epa-supplements
I'm very suspicious of this "medical food" for a number of reasons - although I do find it interesting. I had never heard of a prescription medical food before this one. Would the components of this be tested by the FDA? I think, maybe somewhat cynically, about "natural" supplements available OTC that end up containing synthetic components that are dangerous (thinking of ED "natural" supplements in particular that turn out to have Viagra or other components). But this would seem to have more legitimacy in its prescription status.
I've seen these products pop up in a couple of offices (pamphlets, drug reps, etc.). I had previously heard of phosphotidylserine being used as a supplement for various cognitive issue (Alzheimer's, ADD), but this is a prescription product that somehow combines phosphotidylserine with DHA and EPA.
The company that sells this says that the compound in its products is called Lipicogen (in the case of Vayacog) or Lipirinen (in the case of Vayarin). I've written to the company to get more info to see how this is really different from a combination of phosphotidylserine and EPA/DHA you would consume from foods (meats, fish, beans) or supplements, and I haven't gotten a clear answer.
A doctor I spoke to who prescribes these (a friend, not someone who is involved in any treatment) said that Vayarin and Vayacog can cross the brain-blood barrier but that fish oil and phosphotidylserine cannot, which I found fishy.
Here is my correspondence with the company. If you can help me make sense of this, I would greatly appreciate it!
First e-mail
To [Redacted]:
My main question is whether the ingredients in Vayarin co-exist (like a cocktail drug) or are they somehow synthesized together? In other words, is there any difference in taking the contents of Vayarin separately than taking Vayarin?
I was told by a doctor that the ingredients are in fact somehow fused together rather than simply co-existing as a cocktail supplement, but she didn't know the mechanism of this. She said that your products crosses the blood/brain barrier while over the counter supplements do not. I'm not sure how this could be true as fish oil has been shown to be somewhat effective in treating depression, indicating its chemical components likely cross the blood-brain barrier. The doctor I spoke to had received her information from Vayarin representatives; is this also the position of Vaya Pharma?
Thank you for your time and your information,
[Redacted]
Response:
Dear [Redacted]
Thank you for contacting VAYA Pharma.
I will try and answer all of your concerns.
Vayarin® is a Medical Foods and its efficacy and safety for the dietary management of ADHD were shown in repeated double blind placebo controlled trials, all published in peer reviewed journals.
Attached please find the package inserts, where you can find a short summary and a partial list of the relevant publications.
You will note that PS can potentially interact with some anticholinergic and cholinergic medications and that this is for a physician to address that properly.
The Vayarin® PS-Omega3 molecule is a single molecule rather than a mix and that's the uniqueness of it; the Omega3 fatty acids are chemically bonded to the phospholipid (in this case, the PS). As per superiority to fish oil, we have shown in a pre-clinical trial (also published in peer reviewed journal) that the DHA availability to the brain following oral consumption is superior with the PS-Omega3. This was in comparison to fish oil and to fish oil mixed with soy derived PS. Yes, the fish oil did gain some improvement but not as distinct as our molecule. I'm not sure how familiar you are with the terms but I will say that only the PS-Omega3 molecule achieved statistically significant change (improvement) with compare to the placebo arm.
I wish to add that the Vayarin® molecule is present in breast milk. I cannot state the reason for that but it does present an indication to its safely and some will say necessity as well.
As for prescribing off label, this is entirely in the hands of the physician and I cannot comment on that – good or bad. Generally speaking, to the best of my knowledge, it is a common practice and MDs do that when looking for alternatives, based on their educated knowledge and experience.
Do visit our website for additional information: http://vayarin.com/
Feel free to contact me with any future questions.
Kind regards,
[Redacted]
Second e-mail (never received a response):
Dear [Redacted],
Thank you very much for your response, but I still can't quite put together what Vayarin is.
You explained that the difference is that Vayarin is a single molecule. You must understand I only have a high-school education, and so I am trying to understand this with limited scientific background. What confuses me is that Vayarin is a medical food, but somehow its different components have been synthesized into one molecule. Is that common with food? For example, if you were making a salsa, do the tomatoes and onions combine to form a new molecule? I had always assumed not, but I don't know the answer with absoluteness.
I tried looking at the prescribing information which confused me more.
It says that each Vayarin tablet contains 167 mg Lipirinen, which I assumed was this molecule that is formed from combining EPA, DHA, and phosphatidylserine. But then it goes onto list that each tablet contains a certain number of milligrams of each ingredient. How can it list milligrams of each constituent if those constituents no longer exist in their original forms and combined into one molecule?
So, I looked at the ingredients to further try to figure things out. It lists:
Phosphatidylserine, Hypromellose, Silicon Dioxide, Rosemary Extract (preservative), Mixed Tocopherols (E306-E309), Ascorbyl Palmitate (E304), Titanium Dioxide (color), FD&C Blue #1 (color).
Again, excuse my likely overlooking something, but I don't see any ingredient that would provide EPA or DHA. Below the ingredients, the prescribing information says the product contains krill. But none of those ingredients look like krill.
Finally, there is a drawing of the chemical structure of Vayarin. I finally thought: this will show how it is one molecule. But then I see that there is an asterisk next to Chemical Structure, qualifying that the diagram is a "Schematic structure of one of the most abundant molecules present in Vayarin®."
Which molecule? Is this common in medicine? I would assume that its the molecule of the active ingredient that would be given a diagram, but this could just as easily be a diagram of the silicon dioxide.
I am still just trying to figure out what Vayarin and/or Lipirinen are (if there are any differences between the two).
Is it a dietary supplement that contains phosphatidylserine along with omega-3 oils? I know that you said it isn't, but I still don't see how it's a bonded molecule.
Sincerely,
[Redacted]
Any thoughts on whether this product is really something different than the sum of its parts?
Link to the company:
http://vayapharma.com/selectSystem/default.aspx
Here's the WIkipedia link - it gives a good overview of their claims, as it sounds like it was written by the company:
http://en.wikipedia.org/wiki/Vayarin
Addendum:
Just googling around and come across quite a few threads of parents saying how much Vayarin has helped their children. They all seem to say it makes a difference at the 2 month mark (interesting, as I'm surprised most would be willing to wait it out that long).
Here's one such thread:
http://www.mothering.com/community/...rin-or-phosphatidylserine-dha-epa-supplements
I'm very suspicious of this "medical food" for a number of reasons - although I do find it interesting. I had never heard of a prescription medical food before this one. Would the components of this be tested by the FDA? I think, maybe somewhat cynically, about "natural" supplements available OTC that end up containing synthetic components that are dangerous (thinking of ED "natural" supplements in particular that turn out to have Viagra or other components). But this would seem to have more legitimacy in its prescription status.
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