New Retrospective Study Shows PS-Omega-3 Medical Food Effective in Managing ADHD

Nearly a Third of Children Who Experienced a Benefit While Taking PS-Omega-3 Were Also Able to Reduce Their ADHD Medication Dose

According to a new retrospective study conducted at Texas Child Neurology and Children's Health Services, children diagnosed with attention deficit hyperactivity disorder (ADHD) who took PS-Omega-3 (phosphatidylserine omega-3) medical food experienced a reduction of symptoms and, of these patients, nearly a third of them were able to reduce their ADHD medication while on the medical food. The study’s lead researchers indicated that PS-Omega-3 appears to be a safe and effective non-drug approach for the dietary management of ADHD.

The study was showcased during a poster presentation at the National ADHD Conference from April 7-8, 2016 in Tel Aviv, Israel. The retrospective study, an independent study initiated by Robert Chudnow, M.D. at Texas Child Neurology and Tate Holbrook, M.D. at Children’s Health Services, used VAYA™ Pharma’s Vayarin® PS-Omega-3 as the medical food. The composition found in Vayarin, PS-Omega-3, is a proprietary formulation of phosphatidylserine connected to Omega-3 fatty acids that is an essential structural and biochemical component of cell membranes.

“According to the Centers for Disease Control and Prevention, more than 6 million children in the U.S. suffer from ADHD and the symptoms that accompany the disease, including emotional dysregulation, aggression, impulsivity, hyperactivity, difficulty focusing, among other challenges,” said lead investigator Tate Holbrook, M.D. at Children’s Health Services. “Our analysis showed that patients taking Vayarin reported a reduction in ADHD symptoms and, what’s more, many patients were able to reduce the dose of their current ADHD medication, which may help alleviate unpleasant side effects.”

Study OverviewIn the analysis, the effect of Vayarin was retrospectively evaluated in 518 patients, average age of 11 years, with ADHD. Researchers at Texas Child Neurology in Plano, TX and Children's Health Services in Greenville, NC used electronic health records (EHR) to identify ADHD patients that were administrated Vayarin for different durations.

The effect of Vayarin was assessed based on patient and parent self-assessments. Reduced ADHD symptoms were reported by 68 percent of patients taking Vayarin. Similar response rates (66 percent) were observed for adjunct use of Vayarin with ADHD stimulant and non-stimulant prescription medication. In addition, 31 percent of patients who experienced a benefit while on Vayarin were also able to reduce their dose of ADHD medication.

“Since our clinics specialize in pediatric neurology, we’re continually looking for new ways to safely alleviate the symptoms of ADHD for children and to support their overall quality of life,” commented lead investigator Robert Chudnow, M.D. at Texas Child Neurology. “We are pleased to see – through this retrospective study – that Vayarin helps to bridge the gap of nutritional deficiencies commonly associated with ADHD, giving children and their families a non-drug approach to managing ADHD symptoms.”

VAYA PharmaVAYA Pharma, a division of Enzymotec Ltd (NASDAQ:ENZY), 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), early memory impairment (EMI) and hypertriglyceridemia. Committed to safety and efficacy, VAYA Pharma’s innovations – Vayarin®, Vayacog® and Vayarol® – are backed by years of clinical research. Its products are available in the U.S. by prescription under the supervision of a physician. VAYA Pharma is headquartered in Baltimore, Maryland. For more information, visit www.vayapharma.com.

Forward-Looking StatementsThis press release may contain forward-looking statements related to VAYA Pharma’s business strategy, outlook, objectives, plans, intentions or goals. The words "may," "will," "should," "plans," "explores," "expects," "anticipates," "continue," "estimate," "project," "intend," and similar expressions, identify forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, but their absence does not mean that the statement is not forward-looking. These statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict. Actual results could differ materially. VAYA Pharma expressly disclaim any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company's expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based.

For more information:
VAYA Pharma
Shervin Esfahani
443.995.4299
[e-mail]

Andrea Martin (on behalf of VAYA Pharma)
Andrea D. Martin Consulting, LLC
443.927.6183
[e-mail]