Tris Pharma Presents Results from Two Clinical Studies on Dyanavel® XR at the Largest Annual Meeting of Child and Adolescent Psychiatrists
MONMOUTH JUNCTION, NJ, October 24, 2018 / PRNewswire/ – Tris Pharma, Inc. (Tris), a biopharmaceutical company focused on developing innovative products that deliver meaningful patient benefits, will present new data from two studies on DYANAVEL XR (amphetamine) extended-release oral suspension, CII, at the 65th Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP) taking place in Seattle, Washington, October 22 to 27, 2018. AACAP is the largest international medical congress of child and adolescent psychiatrists.
DYANAVEL XR is approved to treat children six years and older with Attention Deficit/Hyperactivity Disorder (ADHD). Please see important safety information for DYANAVEL XR, including Boxed Warning about Abuse and Dependence, below.
The two posters, to be presented on October 24, are:
1) “Single Dose Pharmacokinetics of Amphetamine Extended-Release Tablet (AMPH ER TAB) Compared with Amphetamine Extended-Release Oral Suspension (AMPH EROS)” and
2) “Open-Label Dose Optimization Study of an Amphetamine Extended Release Oral Suspension in Children with Attention Deficit/Hyperactivity Disorder.”
“These presentations underscore our commitment to furthering knowledge about and advancing research into the unmet needs of children and adolescents with ADHD,” said Barry K. Herman, M.D., M.M.M., Tris’ Chief Medical Officer.
About ADHD
ADHD is one of the most common neurodevelopmental disorders characterized by an ongoing pattern of inattention and/or hyperactivity and impulsivity. These behaviors can interfere with functioning or development. 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.
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 amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. |
- 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.
Please click here for Full Prescribing Information, including Boxed WARNING regarding Abuse and Dependence.
About Tris Pharma
Tris Pharma is a fully integrated pharmaceutical company focused on the development of innovative medicines that address unmet patient needs. Tris has pioneered the delivery of sustained release in the liquid, chewable, orally disintegrating tablet, and strip dosage forms that benefit a wide variety of patients and their unique needs. Tris’ research, manufacturing and commercial facilities are located in Central New Jersey.
For more information, please visit staging.trispharma.com
FOR INFORMATION, CONTACT
Peter Ciano (732) 823-4950
pciano@trispharma.com
DYANAVEL is a registered trademark of Tris Pharma, Inc.
© 2018 Tris Pharma, Inc. All rights reserved.