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Have a question? Please check the list below for our most Frequently Asked Questions.
If you still can’t find your answer, call us at 410-297-0020 or email: firstname.lastname@example.org
What is a medical food?
Unlike dietary supplements that are intended to enhance wellness in healthy populations, medical foods are formulated specifically to manage nutritional deficiencies that are associated with certain diseases and health conditions, including attention deficit hyperactivity disorder (ADHD), autism and early memory impairment (EMI). Medical foods are made of ingredients that receive the U.S. Food and Drug Administration’s (FDA) Generally Recognized as Safe (GRAS) designation; and they are required to be based on scientific evidence to confirm the safety and efficacy of the product.
What are Vayarin’s ingredients?
Vayarin ® is a unique patent protected composition containing generally recognized as safe (GRAS) ingredients. Vayarin ® is derived from krill harvested from the cold waters of the Antarctic Ocean. Vayarin® contains *Silicon dioxide, Ascorbyl palmitate, **Mixed tocopherols, Sunflower oil, Propylene glycol, Distilled monoglycerides, ***Rosemary extract (preservative).
Vayarin® comes in capsule form. The capsule’s outer shell contains: Hydroxypropyl methyl cellulose Caramel (color), Titanium dioxide**** (color).
*silicon dioxide is used as an anti-caking agent
**mixed tocopherols (antioxidants) are used to help protect against oxidation
***rosemary extract is used as a preservative
****titanium dioxide is used for color
Vayarin® does not contain sugar, lactose, yeast or gluten.
Vayarin® is manufactured by VAYA Pharma’s parent company, Enzymotec (NASDAQ: ENZY), located in northern Israel.
What is “PS” in the “PS-Omega-3” of Vayarin®?
Phosphatidylserine (PS) is a phospholipid that is already found in the brain as an important part of the cell structure. It is negatively charged and resides on the inside of the cell membrane, giving it a key role in the maintenance of cellular function and communication. PS is also most abundantly found in the brain, indicating its importance to the brain’s function. There are more than a dozen studies published on the safety and efficacy of PS-Omega-3, VAYA Pharma’s keystone lipid.
PS-Omega-3 contained in Vayarin® plays a double-role:
• It plays a role in the maintenance of cellular function and communication
• It works as a delivery-platform for Omega-3 to the brain
VAYA Pharma’s proprietary structure allows Vayarin® to target the brain, delivering essential lipid to address the lipid deficiency associated with ADHD.
What is the difference between the Vayarin® composition and regular fish oil?
Vayarin® contains Phosphatidylserine-Omega-3 (PS-Omega-3-EPA dominant). Vayarin® is different from an over-the-counter (OTC) omega-3 or PS product, because it contains a unique, specially formulated composition of PS attached to omega-3 (PS-Omega-3). It is this unique structure that allows the composition to target the brain, delivering essential nutrients to address the specific lipid deficiency associated with ADHD.
In a preclinical study (later repeated by different groups with similar outcomes), results showed that PS-Omega-3 increases the bioavailability of Omega-3 fatty acids to brain tissues. In fact, there was a 42% increase in Omega-3 elevation in the brains of rats compared to control, whereas a fish oil plus PS mixture (not bond/attached), did not result in a significant increase as compared to the control.
PS-Omega-3 was evaluated within a population of inattentive children with ADHD. Study findings indicated that the PS-Omega-3 group experienced a marked improvement in visual sustained attention performance, in comparison to both placebo and fish oil supplementation. These findings support the superior beneficial effect of PS-Omega-3 to fish oil.
Why can’t I just buy PS and Omega-3 separately and then take them together?
The differences between Vayarin® and a mixture of supplements, such as PS and Omega-3, were thoroughly investigated in a preclinical study. This study showed that the specially formulated composition of PS-Omega-3 found in Vayarin and Vayacog significantly increased the bioavailability of Omega-3 fatty acids in brain tissues versus the control (or placebo). In fact, there was a 42% increase in Omega-3 elevation in the brains of rats compared to control, whereas a fish oil plus PS mixture (not bond/attached), did not result in a significant increase as compared to the control. The difference is in the structure of the lipids found in Vayarin, and its ability to act as a direct delivery platform to the brain.
Why is the amount of Omega-3 in Vayarin® so low?
Vayarin’s unique composition of phosphatidylserine (PS) attached to Omega-3 fatty acids allows essential lipids to reach the brain. This targeted delivery requires significantly less Omega-3s in each capsule.
Why does Vayarin® have more EPA vs DHA?
Studies have shown that DHA Omega-3 is essential to pre and postnatal brain development and cognition; whereas, EPA Omega-3 is more influential on behavior and mood – two behaviors that are often compromised in children with ADHD.
Why does it take 30-90 days for Vayarin® to start working in the body?
Because Vayarin® are each in their own way compensating for and managing a nutritional deficiency in the brain, unlike pharmaceutical drugs, it takes time to accumulate in the system. It takes an average of 30-90 days for Vayarin® to build up in the body in order to see the full effect on ADHD behaviors.
Does my child have to take Vayarin® forever?
A24: The distinct lipid deficiencies associated with ADHD addressed by Vayarin® cannot be corrected by the modification of diet alone. Only your health care provider can evaluate your condition and make specific recommendations regarding your health.
How much soy is in Vayarin?
The product Vayarin® is marine sourced, specifically Krill. The product label indicates that Vayarin “may contain soy” due to the fact that soy based products are manufactured in the same facility.
Are there any side effects from Vayarin®?
There are virtually no side effects (adverse events) reported from those taking Vayarin®. Vayarin® is clinically shown to be safe and well tolerated in children. The most common side effect reported is gastrointestinal (GI) discomfort.
• Vayarin Clinical study describing safety
: Manor I., et. al. (2013) Safety of phosphatidylserine containing omega3 fatty acids in ADHD children: a double-blind placebo-controlled trial followed by an open-label extension. Eur Psychiatry. Aug;28(6):386-91
What are the sources of Vayarin®?
Vayarin® is made from generally recognized as safe (GRAS) ingredients. Vayarin® is derived from krill harvested from the cold waters of the Antarctic Ocean.
Does Vayarin® contain genetically modified ingredients?
No, Vayarin® is not genetically modified. It is a certified non-GMO product.
Since Vayarin® is marine sourced, should I be concerned about ocean-borne contaminants, like mercury?
VAYA Pharma closely monitors and tests its products for mercury, heavy metals and other potential contaminants (e.g. iodine). Mercury content in all products is below the allowed levels (< 0.1 ppm according to the European regulation (EC) No 629/2008), and U.S. federal and state requirements. VAYA Pharma’s production facility is compliant with current Good Manufacturing Practice (GMP) regulations and abide by all GMP regulatory requirements.
I am (my child is) allergic to soy/fish/shellfish – can I (he/she) still take Vayarin®?
A15: Vayarin® is derived from krill – a shellfish. Within the same facility, there are other production lines where fish and soy products are produced or used. For safety, VAYA Pharma states on the label that Vayarin® may contain soy and fish (e.g. herring, blue whiting, anchovy), although GMP measures are in place to protect against allergen cross-contact. Vayarin® does not contain sugar, lactose, yeast or gluten.
Is the harvesting of fish/krill to source the material for your products sustainable?
VAYA Pharma supports sustainable management of krill and fish populations and an eco-friendly supply chain to maintain the conservation of marine life sources. What’s more, our krill biomass is supplied only from vessels and facilities monitored by members of the Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR).
Where can I find Vayarin®?
VAYA Pharma currently sells its products in the U.S., Singapore, Ukraine, Turkey and Israel. VAYA Pharma is expanding quickly and is actively working to grow in other countries across the world.
or call at 1-844-4VDIRECT (1-844-483-4732)
What is the difference between “FDA approved” and “FDA regulated”?
New drugs must be proven safe and effective to FDA's satisfaction before companies can market them. During the approval process, FDA experts review the results of laboratory, animal and human clinical testing done by manufacturers. If FDA grants an approval, it means the agency has determined that the benefits of the product outweigh the risks for the intended use.
VAYA's product are regulated as medical foods and not pharmaceuticals; therefore they do not go through this regulatory pathway. The medical food category is tightly regulated by FDA. In order to be considered by FDA as a medical food, the products must meet several requirements that are set by FDA. These requirements relate to the quality and safety of the products [i.e.: the product should be produced under current Good Manufacturing Practice (GMP); the product must contain ingredients that are generally recognized as safe (GRAS); the product development must be based on recognized scientific principles].
Where should I store Vayarin®?
High temperatures can impact the efficacy of Vayarin®. We recommend you store the product at a temperature lower than 77° F (25° C) and protect it from light and moisture.
What if my child missed a dose of Vayarin®?
The recommended daily dose for Vayarin® is two (2) capsules daily. As a medical food, Vayarin® addresses nutritional deficiencies associated with ADHD, so if a dose has been skipped or missed, simply take it when you remember and continue as usual. If you have additional questions about dosage, we recommend you speak with your health care provider.
Are there other ways to take Vayarin® if a patient can’t / refuses to swallow pills?
Vayarin’s capsules can be opened and sprinkled on food or mixed with a beverage. The foods and beverages that work best are peanut butter, applesauce, yogurt, jelly and hazelnut spread. For the best taste, be sure to mix it into a cold food or beverage and you’ll want to encourage your child to eat the entire dish.
Can my child take Vayarin® with his or her current ADHD medications? Can I take this product with the other medications that I am taking?
Vayarin® can be a safe and effective medical food to manage nutritional deficiencies and imbalances not addressed by ADHD drug treatments. Vayarin® may be used alongside ADHD medications. Before starting/changing any ADHD management approach including Vayarin®, VAYA Pharma recommends you consult your health care provider.
VAYA Pharma directs all patients to use the products under medical supervision.
Is Vayarin® available Over the Counter (OTC) or is there any generic version that is comparable to Vayarin®?
Vayarin® is a unique composition containing Phosphatidylserine enriched with Omega-3 fatty acids (PS-Omega-3) and has no generic version in the market. Vayarin’s patented and clinically tested composition cannot be found over the counter. Vayarin® composition is indicated for the dietary management of certain lipid imbalances associated with ADHD in children. The differences between Vayarin® and a mixture of supplements, such as PS and Omega-3, were thoroughly investigated in a preclinical study. This study showed that the specially formulated composition of PS-Omega-3 found in Vayarin® significantly increased the bioavailability of Omega-3 fatty acids in brain tissues versus the control (or placebo). In fact, there was a 42% increase in Omega-3 elevation in the brains of rats compared to control, whereas a fish oil plus PS mixture (not bond/attached), did not result in a significant increase as compared to the control. The difference is in the structure of the lipids found in Vayarin®, and its ability to act as a direct delivery platform to the brain.
Why is Vayarin® priced the way it is?
VAYA Pharma invests heavily in the research and development of our products to ensure their safety and efficacy. This research comes with cost. With this being said, VAYA Pharma is dedicated to maintaining prices that make our products affordable. VAYA's goal is to maintain the out of pocket cost to consumers in line with what they would pay for other therapies.
To access VAYA Direct, visit www.vaya-direct.com
or call at 1-844-4VDIRECT (1-844-483-4732).
Does insurance cover Vayarin®?
As medical foods, VAYA Pharma products are not universally covered by insurance. VAYA Pharma is always striving to expand insurance coverage and recommend patients to contact their insurance provider to determine if they are covered. There are instances where insurance providers will provide coverage for our products.
To access VAYA Direct, visit www.vaya-direct.com
or call at 1-844-4VDIRECT (1-844-483-4732)
Are there any coupons/deals that you can offer to help cost?
Promotional discounts are available through VAYA Direct. To access VAYA Direct, visit www.vaya-direct.com
or call at 1-844-4VDIRECT (1-844-483-4732).