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Published on November 12, 2018

• The trial of children 6 to 12 years with ADHD demonstrated that DYANAVEL XR was effective in reducing symptoms of ADHD at 4 hours with a clinical onset at 1 hour and a duration of effect up to 13 hours after dosing

• In a crossover pilot study of children 6 to 12 years with ADHD, DYANAVEL XR reduced ADHD symptoms at 30 minutes after dosing

MONMOUTH JUNCTION, NJ, November 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.

• 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 www.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.