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fMRI Data from Clinical Trial Demonstrate a Proposed Mechanism of Action for the Efficacy of Vayarin® Plus in Adults with ADHD
Study Abstract Presented at the 2019 APSARD Annual Meeting in Washington, DC
COLUMBIA, Md., Jan. 22, 2019 (GLOBE NEWSWIRE) -- VAYA™ Pharma, Inc. (VAYA™), a division of Frutarom, Inc, and leader in developing specialty nutrition, announced today recently completed brain imaging study results utilizing functional magnetic resonance imaging (fMRI). The purpose of this trial was to study the neurobiological basis of response in the brain of adults with Attention Deficit Hyperactivity Disorder (ADHD) after taking Vayarin® Plus, a unique non-drug approach to managing ADHD in adults. The fMRI demonstrated changes in specific parts of the brain which correlated to the product’s effect on the reduction of ADHD severity. A poster presentation of the study abstract and results was recently presented at the 2019 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting in Washington, DC on January 18 – 20, 2019.
"This newly analyzed imaging data provides evidence on the changes in brain activation as a result of administration with Vayarin® Plus. These findings are an important step toward better understanding of the Vayarin® Plus mechanism of action and its correlation to the product’s clinical effect," said Dr. Gali Artzi, director of medical affairs, VAYA™.
Vayarin® Plus fMRI study
The brain imaging study was part of a larger multi center, randomized, double blind, placebo-controlled study of 189 adults with ADHD. The brain activation was tested in 79 adults aged 18-55 years old with ADHD, who received either Vayarin® Plus or a placebo. In the current study, an enrichment design was used to restrict the analyses to participants who did not respond to placebo during the lead-in period. Vayarin® Plus intake resulted in a greater clinical improvement as compared to placebo (p<0.05). This improvement was associated with changes in neuronal activation in areas in the brain governing executive functions and motor planning. The results show, for the first time, that effects related and unrelated to dopamine in the brain may contribute to the clinical benefit of Vayarin® Plus.
The larger study, presented in 2018, met its predetermined primary endpoint and showed significant improvement in ADHD behaviors compared to placebo in the Adult ADHD Investigator Symptom Rating Scale (AISRS). Further analysis revealed new findings on the secondary endpoint, including the Clinical Global Impression – Severity (CGI-S) scale, and the Behavior Rating Inventory of Executive Function (BRIEF).
“We are continuing to explore innovative ways to showcase the efficacy of our specialty nutrition products for children and adults who are managing their ADHD behaviors on a daily basis," said Michelle Cuccia, CEO of VAYA™. "The latest data is fascinating as it leverages the power of an fMRI to show the direct response and brain activity related to taking Vayarin Plus in an adult population. Vayarin Plus is a non-drug approach to help restore the lipid imbalances in the brain that are associated with ADHD. We look forward to continuing our research to help adults diagnosed with ADHD better manage their behavior.”
About Vayarin® Plus
Vayarin® Plus, a new extra-strength product in the Vayarin® product family, is indicated for the clinical dietary management of ADHD in adults and adolescents over the age of 14 who weigh 97 pounds or above (44kgs).
Vayarin® Plus is a line extension of VAYA’s flagship product Vayarin®, a nutritional product intended to support the dietary management of ADHD in children. Literature supports strong correlation between lipid imbalances and ADHD. Vayarin® Plus compensates for and manages these imbalances and was clinically shown to reduce ADHD behaviors safely and effectively, providing full-day coverage.
Vayarin® Plus is available in hard-shell capsule form, that can be also opened and sprinkled on food for easy administration. The recommended daily dose of Vayarin® Plus is 450 mg of Lipirinen®, provided within two capsules per day in convenient once-daily dosing.
For more information about VAYA™ Pharma and about Vayarin® Plus, please visit www.vayadirect.com.
VAYA™ Pharma, a division of Frutarom, Inc., is the innovator of lipid-based medical foods that are used to manage distinct nutritional deficiencies associated with certain diseases and health conditions, including Attention Deficit Hyperactivity Disorder (ADHD) and Early Memory Impairment (EMI). Committed to safety and efficacy, VAYA™ Pharma’s innovations – Vayarin®, Vayarin® Plus and Vayacog® – are backed by years of scientific and clinical research. VAYATM Pharma is headquartered in Columbia, Maryland.
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