May 16 2011
VAYA Pharma (a division of Enzymotec LTD) announced the availability of Vayarin in pharmacies throughout North Carolina, South Carolina and Texas for children suffering with Attention-Deficit / Hyperactivity Disorder (ADHD).
Vayarin, a once-daily formulation of Phosphatidylserine - Omega 3 compound EPA enriched, is prescription-only and offers a new approach to help manage ADHD symptoms in children. Vayarin has been clinically shown to safely reduce disruptive ADHD symptoms including, hyperactivity, inattention, restlessness and impulsivity both at home and at school. Additionally, Vayarin was clinically shown to improve the quality of life for the families of the ADHD children. Vayarin is a Medical Food regulated by the FDA under the Orphan Drug Act and is intended for use under physician supervision with consideration for the distinct nutritional requirements of children suffering with ADHD. Vayarin's recommended dose is 2 capsules once daily or as directed by a physician. It's specially formulated; easy to swallow hard shell capsule can also be opened and sprinkled on food. Vayarin is not a stimulant or a controlled substance and has no potential for abuse or dependence. Yoel Asseraf, CEO of VAYA Pharma division, stated, "Recently conducted market research reveals an unmet need for parents to have an alternative safe approach to help manage ADHD symptoms as it was shown that approximately 50% of the children diagnosed with ADHD are concerned to begin current treatment options. Vayarin specifically addresses this need, as its compounds are familiar to the human body and therefore has a improved safety profile. Vayarin was launched in Israel last year by Teva Pharmaceuticals and the feedback from physicians and parents has been very positive."
Vayarin Clinical Data
Vayarin's clinical study results were recently presented at the Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) in New York and recently accepted for publication in the peer-reviewed journal "European Psychiatry". Vayarin was evaluated in a 30-weeks 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 according to Conners' rating scales and child health questionnaire scores. Additionally, subgroup analysis of children with a hyperactive/impulsive behavior and mood and behavior-dysregulation, revealed a more pronounced reduction in ADHD scores. The double-blind phase was followed by an open-label extension of an 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. "The safety and efficacy data obtained in this study, conducted by Prof. Avi Weizman and Dr. Iris Manor, further support previously reported results indicating that phosphatidylserine-omega 3 EPA enriched, offers a novel safe strategy to help manage ADHD symptoms in children," says Dr. Yael Richter, R&D director of Vaya Pharma division.
ADHD in USA
ADHD is one of the most common psychiatric disorders in children and adolescents. In the United States, approximately 7.8 percent of all school-aged children, or about 4.4 million children ages 4 to 17 years, have been diagnosed with ADHD at some point in their lives. Rick Morris, President and CEO of VAYA Pharma US operations emphasizes that "According to the Centers for Disease Control and Prevention (CDC) the prevalence of ADHD is high especially in South and North Carolina, 12.0% and 15.6% respectively."
Source: VAYA Pharma
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