COLUMBIA, Md., Oct. 26, 2018 (GLOBE NEWSWIRE) — VAYA™ Pharma, Inc. (VAYA™), a division of Frutarom, Inc, and leader in developing specialty nutrition and medical food products, announced today that a new clinical trial “A Randomized, Sequential Parallel, Double-Blind, Placebo-Controlled Medical Food Study for the Safety and Efficacy of Vayarin® in Adults with Attention Deficit Hyperactivity Disorder (ADHD) – “SHARP”, demonstrated the efficacy and safety of Vayarin® Plus for adults with attention deficit hyperactivity disorder (ADHD). The study, recently was presented at the American Academy of Child and Adolescent Psychiatry (AACAP) annual meeting, showed that Vayarin® Plus can safely improve ADHD behaviors in adults diagnosed with ADHD.
“The adult ADHD market is rapidly growing and contains a significant need for effective and safe non-drug options. This clinical study suggests that the new Vayarin® Plus medical food can safely reduce the severity of ADHD symptoms for some adults,” said Prof. Stephen Faraone, Ph.D. distinguished professor of psychiatry and of neuroscience and physiology at SUNY Upstate Medical University Dr. Faraone is a member of the VAYA advisory board and an advisor of the clinical study.
Vayarin® Plus Clinical Study
Vayarin® Plus, studied in a multi-center, double-blind, placebo-controlled clinical trial of 189 participants with ADHD aged 18-60, was shown to effectively and safely improve ADHD behaviors. The clinical trial studied the effect of Vayarin® Plus, phosphatidylserine attached to omega-3 enriched with eicosapentaenoic acid (EPA), on the management of ADHD in adults.
In a per protocol analysis, the study met its predetermined primary endpoint and showed significant improvement 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).
Dr. Faraone elaborated on the advanced Sequential Parallel Comparison Design (SPCD) model used in the study, a novel methodology that reduces both placebo response and sample size. The level of placebo response in psychiatric disorders has been shown to strongly impact the probability of detecting active treatment superiority. In the SPCD model, two treatment phases are utilized, and this allows for a placebo non-responder analysis in the second phase.
Per Protocol Analysis
- ADHD Investigator Symptom Rating Sale (AISRS): Measures aspects of inattention and hyperactive/impulsive behaviors
- In combined phases, a significant improvement of 32% and 27% in the treatment arm compared with placebo was observed in the AISRS Total score (P=0.049) as well as in the AISRS Inattentive score (P=0.016), respectively.
- Behavior Rating Inventory of Executive Function–Adult Version™ (BRIEF-A™), Task Monitoring Subscale: Reflects the ability to keep track of one’s problem-solving success or failure, and to identify and correct mistakes during behaviors
- On top of the improvement in core ADHD symptoms, in combined phases, a significant improvement of 118% was also observed in the BRIEF Task Monitor Scale (P=0.018) in the treatment arm compared with placebo.
- Clinical Global Impression of Severity of Illness (CGI-S): A 7-point scale that requires the clinician to rate the severity of the patient’s illness at the time of assessment, relative to the clinician’s past experience with patients who have the same diagnosis
- A significant reduction in ADHD severity symptoms was observed according to the CGI-S.
Safety and Tolerability Analysis
- Vayarin Plus was shown to be safe and well-tolerated, with no significant adverse events and no significant differences between the two study arms in hematological and biochemical measures.
“We are pleased to have the Vayarin Plus clinical study findings presented to the AACAP scientific community,” said Michelle Cuccia, CEO of VAYA™. “We believe Vayarin® Plus is unique in that it can help adults and adolescents effectively manage their ADHD throughout many aspects of their lives, in a safe and nutrition focused way. It can be a great tool for health care providers across the U.S. who want to use a non-drug approach to manage ADHD around the clock.”
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 medical food for the dietary management of ADHD in children. The products are intended for use under medical supervision. Literature supports strong correlation between lipid imbalances and ADHD. Vayarin® Plus compensates for and manages these imbalances and was clinically shown to reduce ADHD symptoms 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 clinical research. VAYATM Pharma is headquartered in Columbia, Maryland.
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