Vayarin, is a prescription medical food for the clinical dietary management of certain lipid imbalances associated with attention deficit hyperactivity disorder (ADHD) in children. Vayarin contains Lipirinen™, a proprietary composition containing phosphatidylserine-omega 3, EPA (Eicosapentaenoic acid) enriched. Vayarin was developed by VAYA Pharma (a division of Enzymotec LTD), a specialty pharmaceutical company. The VAYA Pharma portfolio addresses three therapeutic segments: ADHD (Vayarin), Hypertriglyceridemia (Vayarol) and memory impairment (Vayacog).Vayarin represents a new approach to helping manage attention deficit hyperactivity disorder symptoms in children. It is a medical food regulated by the U.S. Food and Drug Administration (FDA) under the Orphan Drug Act and is intended for the distinct nutritional requirements of children under a physician’s supervision and by prescription only.
Phosphatidylserine and omega-3 fatty acids
Phospholipids, such as phosphatidylserine (PS), are a class of lipids that serve as the major building blocks for all cell membranes. PS, a vital phospholipid, plays an important role in the normal functioning of brain cells. Human brain cell membranes are highly enriched with PS, as compared to other tissues. Nerve cells in particular, depend on healthy membrane function for normal neuro-transmitter metabolism and nerve signal transmission. PS levels in these tissues ensure membrane fluidity and structure. Furthermore, maintaining brain PS levels has been found to be associated with normal and efficient signal transduction processes, efficient glucose consumption and other biological pathways that are crucial for ensuring normal and healthy cognitive and mental functions. Chemically, the PS molecule consists of a glycerol-phosphate backbone, serine and two fatty acids. It is an amphipatic molecule due to the negatively charged head group (hydrophilic) and its fat-soluble fatty acid tails (lipophilic). The fatty acid composition of endogenous PS depends on its localization and function in the cell. For instance, brain and eye PS are highly enriched with Omega-3 fatty acids. Omega-3 fatty acids are polyunsaturated fatty acids that have been found to have unique and important health benefits. Epidemiological studies  suggest that dietary consumption of Omega-3 LC-PUFA, especially eicosapentaenoic acid (EPA) and DHA, affect neuropsychiatric disorders, presumably due to their structural and neurochemical involvement in pathophysiological processes.
Decreased levels of omega-3 fatty acid are associated with ADHD
Several studies indicate that decreased levels of Omega-3 fatty acids have been associated with several neuropsychiatric conditions, including, attention deficit  schizophrenia, depression and ADHD. Poor metabolism of Omega-3 LC-PUFA has been suspected to be associated with ADHD since the 1980s. It has been reported that plasma and red blood cells levels of EPA and DHA were significantly lower in ADHD patients as compared to control groups . Similar observations were also reported in ADHD adults. Accordingly, it was hypothesized that supplementation of LC-PUFA, like EPA and DHA, may lead to an improvement in the symptoms of ADHD. However, the results of supplementation of these LC-PUFAs with or without vitamins have been inconclusive. Recently, it was reported that PS containing omega-3 LC-PUFA may reduce ADHD related symptoms in children.
Two Vayarin capsules provide:
- Phosphatidylserine (PS): 150 mg
- Eicosapentaenoic acid (EPA): 43 mg
- Docosahexaenoic acid (DHA): 17 mg
Administration and dosing
Vayarin is specially formulated for children's consumption, it is available as hard shell capsules that can be opened and sprinkled on food. It is not a stimulant or a controlled substance and has no potential for abuse or dependence. Vayarin recommended dose is two capsules once a day or as directed by a physician.
Vayarin was evaluated in a 30-week clinical trial. The first phase of the study consisted of a 15-week double-blind, randomized, placebo-controlled study of 200 ADHD children. Significant differences were observed between Vayarin and placebo groups in Conners’ rating scales and child health questionnaire scores. In addition, subgroup analysis of children with a hyperactive/impulsive behavior, as well as mood and behavior-dysregulation, revealed a more pronounced reduction in ADHD scores. The double-blind phase was followed by an open-label extension of additional 15-weeks during which all children received Vayarin. Safety data, obtained during both the double-blind study and the open-label extension, showed that Vayarin was well tolerated with no significant side effects.These results are consistent with previously reported beneficial effects of phosphatidylserine-omega 3 compound in ADHD children.
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