MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)--Tris Pharma, Inc. (“Tris”) announced that results from a laboratory classroom study of DYANAVEL XR (amphetamine) extended-release oral suspension, CII, the first and only extended-release liquid amphetamine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children aged six years and older, were presented at the 2017 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting held in Washington, D.C. The study concluded that DYANAVEL XR was effective in reducing symptoms of ADHD from one to 13 hours after dosing in children aged six to 12 years, with a safety profile similar to other extended-release amphetamines.
The findings were presented in a poster, “The Efficacy and Safety of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in Children With ADHD,” presented by Ann C. Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine, Las Vegas, NV. The presentation was selected by the APSARD organizers to be featured in the conference Poster Tour.
“It’s important to establish and maintain effective control of symptoms in children with ADHD,” said Dr. Childress. “This study demonstrates the effectiveness of DYANAVEL XR in both onset of action at 1 hour post-dose, and a duration of efficacy extending to 13 hours post-dose.”
“Tris is committed to providing pediatric-friendly treatment options for children,” said Sally A. Berry, M.D., Ph.D., Chief Medical Officer for Tris Pharma. “This work is evidence of our efforts to produce complete profiles of our pediatric products through robust research to inform clinical decision making. Doctors and their patients deserve no less.”
About the Study
The trial was designed as a dose-optimized, randomized, double-blind, placebo-controlled laboratory classroom study in patients aged six to 12 years with ADHD. The study enrolled 108 patients. Efficacy was assessed by school teachers and raters using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale, which is a standard tool that assesses behavior and attention in laboratory classroom studies.
Key findings include:
- DYANAVEL XR met its primary endpoint of change from pre-dose in the SKAMP-Combined score at 4 hours post-dosing (P<0.0001).
- DYANAVEL XR also met key secondary endpoints by demonstrating an onset of clinical effect at one hour that persisted through 13 hours post-dosing compared to placebo.
- DYANAVEL XR was well tolerated in this study, with a safety profile similar to other extended release amphetamines.
DYANAVEL XR received approval from the U.S. Food and Drug Administration (FDA) in October 2015. Based on clinical trial experience with DYANAVEL XR, side effects appear to be similar to other once-daily ADHD medicines with the same active ingredient. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6–12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).
As is the case with other stimulant medications because of its potential for abuse, DYANAVEL XR is classified as a controlled substance (CII).
ADHD is one of the most common neurobehavioral disorders characterized by an ongoing pattern of inattention and/or hyperactivity/impulsivity. These behaviors can interfere with functioning or development.1 According to the Centers for Disease Control and Prevention’s 2011 data, 11 percent of children aged four to 17 years in the U.S. have received an ADHD diagnosis at some point in their life.2
IMPORTANT SAFETY INFORMATION AND INDICATION
DYANAVEL® XR (amphetamine) extended-release oral suspension is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
IMPORTANT SAFETY INFORMATION
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including DYANAVEL XR, other
DYANAVEL XR is contraindicated
- In patients known to be hypersensitive to amphetamine, or other components of DYANAVEL XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported
- During treatment with monoamine oxidase inhibitors (MAOIs) and within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis
- Prior to and during treatment, assess for the presence of cardiac disease. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment.
- CNS stimulants can cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
- CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Prior to treatment, assess for the presence of bipolar disorder.
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD. Monitor weight and height in children during treatment with DYANAVEL XR. Treatment may need to be interrupted in children not growing as expected.
- CNS stimulants, including DYANAVEL XR, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
- Serotonin syndrome risk is increased when amphetamines are co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during over-dosage situations. If it occurs, discontinue all serotonergic agents and initiate supportive treatment.
- Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia. There is limited experience with DYANAVEL XR in controlled trials. Based on this limited experience, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6–12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).
- DYANAVEL XR use during pregnancy may cause fetal harm.
- Breastfeeding is not recommended during treatment with DYANAVEL XR.
About Tris Pharma
Tris Pharma, Inc. is a specialty pharmaceutical company focused on the research and development of innovative technology-driven products. As an emerging leader in the field of pediatric medicine, Tris Pharma will focus its brand business on neurobehavioral disorders in pediatric patients. Tris has pioneered the delivery of extended-release formulations in the liquid, chewable, orally disintegrating tablet (ODT) and strip dosage forms. The Tris R&D and manufacturing facilities are located in Monmouth Junction, N.J., USA. For more information, please visit www.trispharma.com
DYANAVEL is a registered trademark of Tris Pharma, Inc. © 2017 Tris Pharma, Inc. All rights reserved.
1American Psychiatric Association. Diagnostic and
Statistical Manual of Mental Disorders. 5th ed. Arlington, VA:
American Psychiatric Association; 2013.
2Visser SN, Danielson ML, Bitsko RH, et al. Trends in the parent-report of health care provider-diagnosed and medicated attention-deficit/hyperactivity disorder: United States, 2003-2011. J Amer Acad Child Adolesc Psychiatry. 2014;53(1):34-46.