"This newly analyzed imaging data provide 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.
The brain imaging study was part of a larger multicenter, 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.”