Improved Academic Performance and Medication Rebound in Patients with ADHD Following the Use of Vayarin®, a Multi-Year, Real-World Retrospective Study

BALTIMORE, Jan. 10, 2017 -- Up to 75 percent of individuals with Attention Deficit Hyperactivity Disorder (ADHD) experience emotional dysregulation, according to Research in Developmental Disabilities. Emotional dysregulation is characterized by rapid, poorly controlled shifts in emotion, mood swings and behavioral outbursts. Studies have shown that individuals with ADHD and emotional dysregulation have significantly more impaired peer relationships, family life and academic performance than those diagnosed with ADHD alone. A new multi-year retrospective study initiated by Robert Chudnow, M.D. at Texas Child Neurology looked at patients’ reports on long-term impact of Vayarin^® PS-Omega-3 medical food on patients with ADHD along with indicators for emotional dysregulation, academic performance and medication rebound. A poster presentation about the study will be featured at the American Professional Society of ADHD and Related Disorders (APSARD) annual meeting January 13-15, 2017 in Washington, DC.

Results at a Glance
The lead investigators found that 68 percent of children with ADHD who added Vayarin^® to their ADHD management routine reported general improvements following a short and long-term administration period (an average of six and 36 months, respectively) of the medical food. For example, patients reported improvements in their academic performance (58 percent) and emotional regulation (51 percent). Emotional dysregulation is a component of ADHD that has been shown to predict poor long-term clinical and educational outcomes in early-adulthood, such as academic performance. Additionally, 38 percent of patients who suffer from medication rebound reported improvement in the rebounding effect. Medication rebound is characterized by the re-emergence of ADHD symptoms after prescription medications – including stimulants – wear off.

“The results of this retrospective study are extremely promising for patients with ADHD who also suffer from emotional dysregulation and have other challenges that impact their well-being,” said Dr. Gali Artzi, director of medical affairs, VAYA Pharma. “The results are also exciting because the population included patients with real-world experiences – patients who are taking different medications, have different co-morbidities and have struggled day-to-day with the impact of ADHD on many parts of their lives. The improvements shown by the participants in this study further support the benefit of Vayarin^® in patients with ADHD. We are thrilled to have this research featured at the 2017 APSARD annual meeting.”  

The investigator-initiated retrospective study analyzed 518 patients with ADHD. The effects of Vayarin^® based on patients’ reports were evaluated by a clinician using the Clinical Global Impression of Change (CGIC) scale, as well as a self-rated outcome tool. The study was funded by a grant from VAYA Pharma and the use of VAYA Pharma’s Vayarin^® medical food was analyzed in the results.

About Vayarin^®
Vayarin^® is a prescription medical food for the dietary management of complex lipid imbalances associated with ADHD. Vayarin’s unique lipid composition allows it to effectively deliver lipids to the brain, across the blood brain barrier. Previously, in a double-blind placebo controlled clinical study, this composition was shown to significantly reduce ADHD behaviors, especially in children with emotional dysregulation. Vayarin^® is safe and well tolerated in children, with side effects that were equivalent to placebo.

VAYA Pharma
VAYA 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 for use under the supervision of a physician. VAYA Pharma is headquartered in Baltimore, Maryland. For more information, visit www.vayapharma.com.

Forward-Looking Statements
This press release may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended 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. Such statements involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Some of the important factors that could cause or contribute to such differences include the following: our ability to gain commercial benefit from such depends on many uncontrolled factors; offering of products as "medical foods" in the United States may be challenged by regulatory authorities; we are not able to predict the final results of clinical trials, which may prove unsuccessful or be delayed by certain factors and other factors discussed under the heading "Risk Factors" in Enzymotec Ltd's annual report on Form 20-F for the year ended December 31, 2015 filed with the Securities and Exchange Commission on March 3, 2016. You should not put undue reliance on any forward-looking statements and VAYA Pharma and Enzymotec Ltd. cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. These forward-looking statements are made only as of the date hereof, and VAYA Pharma and Enzymotec Ltd. expressly disclaim any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the 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
[email protected]

Andrea Martin (on behalf of VAYA Pharma)
Andrea D. Martin Consulting, LLC
443.927.6183
[email protected]