Media

• Tris announces the publication of a Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of DYANAVEL XR Tablets in Adults with ADHD in the Journal of Clinical Psychiatry. The article can be found here.
• The study demonstrated that DYANAVEL XR tablets are an effective and well-tolerated treatment for the symptoms of ADHD in adults.
• These results build on previous clinical results in pediatric patients demonstrating efficacy with DYANAVEL XR oral suspension as early as 30 minutes after administration.

MONMOUTH JUNCTION, NJ, July 22, 2022 / PRNewswire/ – Tris Pharma, Inc. (“Tris”), a fully integrated pharmaceutical company with a robust portfolio of CNS products announced the publication of a Phase 3 study in the Journal of Clinical Psychiatry that demonstrated that adult patients with ADHD who took DYANAVEL XR (amphetamine) tablets CII had statistically significant improvement in symptoms over patients who took placebo.

The study was a Phase 3, randomized, double-blind, placebo-controlled, fixed-dose study designed to assess the efficacy and safety of DYANAVEL XR tablets in adult patients with ADHD. The efficacy assessment included the administration of serial Permanent Product Measure of Performance (PERMP) tests pre-dose and at 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post dose. The mean PERMP Total (PERMP-T) score across all post dose time points – the primary efficacy endpoint – was statistically significantly higher in the DYANAVEL XR tablet group compared with placebo (302.8 vs 279.6; p=0.0043). Additionally, statistically significant improvements (increase) in PERMP-T scores were observed in the DYANAVEL XR tablet group at 0.5 hours (p=0.01), 1 hour (p< 0.001), 2 hours (p= 0.0003), 4 hours (p = 0.031), 8 hours (p = 0.026), and 13 hours (p=0.006) post dose compared with placebo. Numerical differences favoring the DYANAVEL XR tablet group were seen at the 10-, 12-, and 14-hour time points as well, however those differences were not statistically significant when compared to placebo. The most common adverse events included headache, decreased appetite, irritability, initial insomnia, insomnia, dry mouth, anxiety, dizziness, tachycardia, fatigue, and nausea. Most treatment-emergent AEs (TEAEs) were mild to moderate in severity, and no SAEs were reported during the study.

“The results of this study demonstrate the efficacy of the amphetamine extended-release tablet in the treatment of ADHD in adults,” said Andrew J. Cutler, MD, Clinical Associate Professor of Psychiatry, SUNY Upstate Medical University and the principal investigator of the study. “When you look at the totality of the efficacy results, coupled with what we know about DYANAVEL XR pharmacokinetics and pharmacodynamics, you can see that the drug is working shortly after dosing, and is still providing efficacy 13 hours post dose.”

DYANAVEL XR employs Tris’s unique LiquiXR® platform technology, which allows immediate-release products to be transformed into products with both immediate-release and extended-release characteristics and permits once-daily dosing.

The article can be accessed here in the Journal of Clinical Psychiatry.

About Tris Pharma

Tris is a fully integrated, innovation-driven CNS company that provides a differentiated approach to target unmet medical needs, including the application of novel technologies designed to enhance patient benefits across therapeutic categories.

Tris’s CNS portfolio includes treatments for pain; addiction; spasticity in multiple sclerosis, cerebral palsy; narcolepsy; and ADHD. For more information, please visit www.trispharma.com and www.trismedical.com.

DYANAVEL and LiquiXR are registered trademarks of Tris Pharma, Inc.

APPROVED USE
DYANAVEL XR is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. DYANAVEL XR may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.

IMPORTANT SAFETY INFORMATION
DYANAVEL XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep DYANAVEL XR in a safe place to prevent misuse and abuse. Selling or giving away DYANAVEL XR may harm others, and is against the law. 

Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

DYANAVEL XR should not be taken if you or your child are allergic to amphetamine or any of the ingredients in DYANAVEL XR, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.

DYANAVEL XR can cause serious side effects. Tell the doctor:

• if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children 6 to 17 years old with heart problems or defects, and sudden death, stroke, and heart attack have happened in adults. Your doctor should check you or your child carefully for heart problems before starting DYANAVEL XR. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment.  Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking DYANAVEL XR.
• if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur.  Call the doctor right away if there are any new or worsening mental symptoms during treatment.
• if you or your child have circulation problems in fingers and toes (called peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature, and/or change color from pale, to blue, to red.  Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking DYANAVEL XR.
• if your child is having slowing of growth (height and weight); Your child should have his or her height and weight checked often while taking DYANAVEL XR.
• if you or your child have symptoms of serotonin syndrome – agitation, hallucinations, coma, or other changes in mental status; fast heartbeat; sweating or fever; nausea, vomiting, diarrhea; high or low blood pressure; problems controlling movements or muscle twitching; muscle stiffness or tightness. Serotonin syndrome may occur when DYANAVEL XR is taken with certain other medicines and may be life-threatening. Stop DYANAVEL XR and call your doctor or go to the nearest hospital emergency room.
• if you or your child are pregnant or plan to become pregnant. It is not known if DYANAVELXR will harm your unborn baby. Tell your doctor if you or your child become pregnant during treatment with DYANAVEL XR.
• if you or your child is breastfeeding or plan to breastfeed.  DYANAVELXR passes into breast milk. You or your child should not breastfeed while you are taking DYANAVEL XR.

Common side effects of amphetamine products include:

• dry mouth
• stomach pain
• restlessness
• increased heart rate
• decreased appetite
• weight loss
• nausea
• trouble sleeping
• extreme mood changes
• dizziness

Talk to your doctor if you or your child have any side effects that bother you or do not go away.

Avoid drinking alcohol while taking DYANAVELXR.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Full Prescribing Information, including Boxed Warning about Abuse and Dependence, and Medication Guide.

References
Cutler AJ, Childress AC, Pardo A, et al. Randomized, double-blind, placebo-controlled, fixed-dose study to evaluate the efficacy and safety of amphetamine extended-release tablets in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2022; 83(00):22m14438. doi:10.4088/JCP.22m14438

Pardo A, Kando JC, King TR, Rafla E, Herman BK. Single-dose pharmacokinetics of amphetamine extended-release tablets compared with amphetamine extended-release oral suspension. CNS Spectr. 2020;25(6):774-781. doi:10.1017/S1092852919001676

Pardo A, King TR, Rafla E, Kando JC. Assessing Palatability of a New Amphetamine Extended-Release Tablet Formulation for the Treatment of ADHD. Drug Des Devel Ther. 2021;15:2979-2985. Published 2021 Jul 8. doi:10.2147/DDDT.S309378