New Retrospective Study to be Presented at The American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting January 13-15, 2017 in Washington DC.
In a release issued under the same headline January 10, 2017 by VAYA Pharma, please note that in the first paragraph under Results at a Glance, “38 percent of patients who suffer” should read “65 percent of patients who suffer.” The corrected release follows:
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, 65 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.
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.
Taken from globenewswire