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Once daily extended release provides early onset and full day coverage

MONMOUTH JUNCTION, NJ, October 19, 2022 PRNewswire/ – Tris Pharma, Inc. (Tris) a fully integrated pharmaceutical company with a robust portfolio of CNS products announced today that DYANAVEL^® XR (amphetamine) extended-release tablets, for oral use, CII and DYANAVEL^® XR (amphetamine) extended-release oral suspension, CII are stocked by wholesalers and continue to be available in pharmacies. DYANAVEL XR was approved by the U.S. Food and Drug Administration for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Dyanavel XR may be an option for health care providers and patients who can no longer fill their prescription of Adderall due to a stocking shortage.

In a double-blind, placebo-controlled, fixed-dose Phase 3 study in adults with ADHD, DYANAVEL XR tablets demonstrated statistically significant improvement versus placebo in mean Permanent Product Measure of Performance Total (PERMP-T) scores averaged across all measured post-dose time points (0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours post-dose). The PERMP-T is a validated and FDA-accepted, skill-adjusted, timed math test that is used to assess attention in people with ADHD. 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. These finds were recently published in The Journal of Clinical Psychiatry (Cutler, et al. J Clin Psychiatry 2022. 83(00):22m14438).

In another clinical study in healthy adults, DYANAVEL XR extended-release tablets were deemed to be bioequivalent to DYANAVEL XR (amphetamine) extended-release oral suspension CII, which in a Phase 3 clinical study of children aged 6 to 12 years with ADHD, demonstrated ADHD symptom improvement within 1 hour, that lasted through 13 hours after once-daily dosing.

“With the Innovative Tris portfolio of ADHD products, we are committed to help Providers and Patients through their treatment journey. DYANAVEL XR Tablet and DYANAVEL XR oral suspension provide quality treatment options for adult and pediatric patients 6 years and older with ADHD who need an amphetamine”, said Dr. James Hackworth, President of the Tris Branded Products Division.

DYANAVEL XR is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep DYANAVEL XR in a safe place to protect it from theft. Never give your DYANAVEL XR to anyone else because it may cause death or harm them. Selling or giving away DYANAVEL XR may harm others and is against the law. See additional important safety information below.

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.

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 DYANAVEL XR 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. DYANAVEL XR 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 DYANAVEL XR.

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

1. 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
2. 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

DYANAVEL^® is a registered trademark of Tris Pharma, Inc.
©2022 Tris Pharma, Inc. All rights reserved.