Vayarin

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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. 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.

Background[edit]

Phosphatidylserine and omega-3 fatty acids[edit]

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.[1][2][3][4] 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 [5][6] 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[edit]

Several studies indicate that decreased levels of Omega-3 fatty acids have been associated with several neuropsychiatric conditions, including, attention deficit [7] schizophrenia, depression and ADHD.[8] 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.[8] 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.[9][10][11][12][13][14] Recently, it was reported that PS containing omega-3 LC-PUFA may reduce ADHD related symptoms in children.[15]

Composition[edit]

Two Vayarin capsules provide:

Administration and dosing[edit]

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.

Clinical data[edit]

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.[16] 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.[17]

See also[edit]

References[edit]

  1. ^ McDaniel, M.A., S.F. Maier, and G.O. Einstein, “Brain-specific” nutrients: a memory cure? Nutrition, 2003. 19(11-12): p. 957-75
  2. ^ Mozzi, R., S. Buratta, and G. Goracci, Metabolism and functions of phosphatidylserine in mammalian brain. Neurochem Res, 2003. 28(2): p. 195-214
  3. ^ Pepeu, G., I.M. Pepeu, and L. Amaducci, A review of phosphatidylserine pharmacological and clinical effects. Is phosphatidylserine a drug for the ageing brain? Pharmacol Res, 1996. 33(2): p. 73-80
  4. ^ Vance, J.E. and R. Steenbergen, Metabolism and functions of phosphatidylserine. Prog Lipid Res, 2005. 44(4): p. 207-34
  5. ^ Hibbeln, J.R., Fish consumption and major depression. Lancet, 1998. 351(9110): p. 1213
  6. ^ Noaghiul, S. and J.R. Hibbeln, Cross-national comparisons of seafood consumption and rates of bipolar disorders. Am J Psychiatry, 2003. 160(12): p. 2222-7
  7. ^ Tully, A.M., et al., Low serum cholesteryl ester-docosahexaenoic acid levels in Alzheimer’s disease: a case-control study. Br J Nutr, 2003. 89(4): p. 483-9
  8. ^ a b Young, G. and J. Conquer, Omega-3 fatty acids and neuropsychiatric disorders. Reprod Nutr Dev, 2005. 45(1): p. 1-28
  9. ^ Hirayama,S., Hamazaki,T. and K. Terasawa, Effect of docosahexaenoic acid-containing food administration on symptoms of attention-deficit/hyperactivity disorder - a placebo-controlled double-blind study. Eur J Clin Nutr, 2004. 58(3): p. 467-73
  10. ^ Richardson, A.J., Clinical trials of fatty acid treatment in ADHD, dyslexia, dyspraxia and the autistic spectrum. Prostaglandins Leukot Essent Fatty Acids, 2004. 70(4): p. 383-90
  11. ^ Richardson, A.J. and P. Montgomery, The Oxford-Durham study: a randomized, controlled trial of dietary supplementation with fatty acids in children with developmental coordination disorder. Pediatrics, 2005. 115(5): p. 1360-6
  12. ^ Richardson, A.J. and B.K. Puri, A randomized double-blind, placebo-controlled study of the effects of supplementation with highly unsaturated fatty acids on ADHD-related symptoms in children with specific learning difficulties. Prog Neuropsychopharmacol Biol Psychiatry, 2002. 26(2): p. 233-9
  13. ^ Stevens, L., et al., EFA supplementation in children with inattention, hyperactivity, and other disruptive behaviors. Lipids, 2003. 38(10): p. 1007-21
  14. ^ Voigt, R.G., et al., A randomized, double-blind, placebo-controlled trial of docosahexaenoic acid supplementation in children with attention-deficit/hyperactivity disorder. J Pediatr, 2001. 139(2): p. 189-96
  15. ^ Kidd, P.M., Attention deficit/hyperactivity disorder (ADHD) in children: rationale for its integrative management. Altern Med Rev, 2000. 5(5): p. 402-28
  16. ^ Manor, I., et al., The effect of Phosphatidylserine containing Omega3 fatty acids on Attention-Deficit Hyperactivity Disorder Symptoms in Children - Part I: A Double-Blind Placebo-Controlled Trial. European Psychiatry 2011
  17. ^ Vaisman, N., et al., Correlation between changes in blood fatty acid composition and visual sustained attention performance in children with inattention: effect of dietary n-3 fatty acids containing phospholipids. Am J Clin Nutr, 2008. 87(5): p. 1170-80