MONMOUTH JUNCTION, N.J., Nov. 12, 2018 /PRNewswire/ -- Tris Pharma, Inc. (Tris), a biopharmaceutical company focused on developing innovative products that deliver meaningful patient benefits, today announced that it presented four scientific posters on DYANAVEL XR at the 2018 NEI Congress in Orlando, FL, November 7 – 11, 2018.
DYANAVEL XR is approved to treat children six years and older with Attention Deficit/Hyperactivity Disorder (ADHD). DYANAVEL XR, a central nervous system (CNS) stimulant, has a Boxed Warning about abuse and dependence. The risk of abuse should be assessed prior to prescribing DYANAVEL XR, and patients on therapy should be monitored for signs of abuse and dependence. DYANAVEL XR is contraindicated in patients with known hypersensitivity to amphetamines or other ingredients in DYANAVEL XR and in patients who are taking, or have taken within the last 14 days, a monoamine oxidase inhibitor (MAOI). Please see additional Important Safety Information below.
"Tris is committed to providing differentiated pediatric-friendly treatment options for children with ADHD," said Ketan Mehta, President and Chief Executive Officer of Tris. "DYANAVEL XR was developed utilizing our proprietary LiquiXR® technology delivery platform. Data from studies presented at the NEI Congress provide further insight into the role DYANAVEL XR could play in the clinical management of patients with ADHD."
The following scientific posters were presented at the NEI Congress:
Poster 32
Title: Early-Onset Efficacy and Safety Pilot Study of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in the Treatment of Children with Attention-Deficit/Hyperactivity Disorder
Author Conclusion: AMPH EROS was effective in reducing ADHD symptoms at 30 minutes postdose. AEs were mild or moderate and consistent with those of other extended-release amphetamines.
Poster 88
Title: The Efficacy and Safety of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in Children with Attention-Deficit/Hyperactivity Disorder
Author Conclusion: AMPH EROS was effective in reducing symptoms or ADHD from 1 to 13 hours after dosing. Adverse events reported were consistent with those of other amphetamine products.
Poster 87
Title: Open-Label Dose Optimization Study of an Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder
Author Conclusion: AMPH EROS was effective in reducing symptoms of ADHD in the OL dose optimization phase of a pivotal phase 3 analog laboratory classroom study. The AE profile of AMPH EROS was consistent with that of other amphetamine products.
Poster 89
Title: A Modified-Release Drug Delivery Technology Containing Amphetamine-Ion Exchange Complexes
Author Conclusion: The release characteristics of the LiquiXR® drug delivery technology are programmable and allow for a customized, sustained release of active drug product, and confer a specific product profile for AMPH EROS.
"The data presented at the 2018 NEI Congress underscore Tris' commitment to furthering research in and advancing the treatment of ADHD," stated Barry K. Herman, M.D., M.M.M., Senior Vice President and Chief Medical Officer of Tris.
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.
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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 www.trispharma.com
DYANAVEL is a registered trademark of Tris Pharma, Inc.
© 2018 Tris Pharma, Inc. All rights reserved.
SOURCE Tris Pharma, Inc.