Amphetamine/Amphetamine Aspartate/Dextroamphetamine Sulfate

-- National direct-to-patient program allows patients and caregivers to obtain DYANAVEL XR extended-release tablet prescriptions from digital pharmacy -- MONMOUTH JUNCTION, N.J.--(BUSINESS WIRE)-- Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced a new partnership with Perigon Pharmacy 360, a full-service, specialty digital pharmacy, to enhance accessibility, affordability and adherence for patients treating symptoms of ADHD with Tris’ DYANAVEL® XR (amphetamine) extended-release tablets. Together, Tris Pharma and Perigon launched a direct-to-patient program, DYANAVEL Delivered, that allows patients and caregivers to seamlessly access DYANAVEL XR extended-release tablets through Perigon’s digital pharmacy, enhance their medication management, and receive reimbursement assistance and support to help navigate their treatment journey while reducing administrative burden for both patients and providers. The program is available across the United States, enabling nationwide access to DYANAVEL XR extended-release tablets. Patients and physicians wishing to access the DYANAVEL Delivered program can learn more at . “This partnership underscores our continued commitment to ensuring patients have access to the medications they need to treat their ADHD symptoms,” said Ketan Mehta, founder and CEO at Tris Pharma. “In an environment where shortages have been significant and widespread for more than a year, Tris Pharma is among the relatively few companies that have managed to not only maintain but increase supply of our ADHD medications without interruption. Our program with Perigon builds on this success by offering patients a more convenient way to consistently obtain access to their DYANAVEL XR extended-release tablet prescription.” Since the November 2021 approval of DYANAVEL XR extended-release tablets, Tris Pharma has seen a consistent increase in prescription volume and taken steps to manage manufacturing volume to ensure that the company is able to consistently meet and exceed demand. The DYANAVEL Delivered program is designed to help eliminate bottlenecks by delivering DYANAVEL XR extended-release tablets directly to patients and caregivers. “We’re incredibly excited to partner with Tris Pharma on this program, because we believe it has the potential to enhance quality of care and reduce prescription access challenges for ADHD patients during a particularly critical time,” said Ted Mills, CEO at Perigon Pharmacy 360. “Additionally, this partnership will provide important insights about the impact of innovative technology and advanced healthcare solutions on real-world patient outcomes.” DYANAVEL XR extended-release tablets are approved for the treatment of ADHD in patients aged 6 years and older. This medication is developed using Tris Pharma’s proprietary LiquiXR® technology to create a non-degrading diffusion coating that offers a consistent, controlled release of medication over time. 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 Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological disorders, including addiction and diseases of the central nervous system. Tris is an established commercial organization with a robust portfolio of best-in-class ADHD products and a promising pipeline of differentiated, near-term drug candidates. More information is available at and on LinkedIn @TrisPharma. About Perigon Pharmacy 360 Perigon Pharmacy 360 is an independent specialty pharmacy that is working to provide care and support to those in need. Perigon serves patients in all 50 states, plus D.C., and are focused on helping improve the patient experience through access to medications, caregiver awareness, provider engagement, and clinical support of our Care Teams. Perigon also utilizes the proprietary Medesto platform, together with the specialty and traditional care pharmacy, to create a Precision Digital Pharmacy model with the goal of improving medication adherence and, clinical outcomes. Perigon Pharmacy 360 is redefining the manner in which patients interact with the critical role of the Pharmacist. For more information, please visit INDICATION DYANAVEL XR is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in patients 6 years and older. IMPORTANT SAFETY INFORMATION WARNING: ABUSE, MISUSE, AND ADDICTION DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 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 with other amphetamines. in patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of increased risk of hypertensive crisis. Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with DYANAVEL XR, assess for the presence of cardiac disease. Avoid DYANAVEL XR use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment. CNS stimulants cause increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension. Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce maniac or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage. Prior to initiating DYANAVEL XR treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing DYANAVEL XR CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD; monitor weight and height 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. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for DYANAVEL XR-treated patients who develop signs or symptoms of peripheral vasculopathy. Serotonin syndrome risk is increased when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment. CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating DYANAVEL XR, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor DYANAVEL XR-treated patients for the emergence or worsening of tics or Tourette’s syndrome and discontinue treatment if clinically appropriate. Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia. Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction pro 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 to 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. To monitor pregnancy outcomes in women exposed to DYANAVEL XR during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at . Because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with DYANAVEL XR. To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or . Please see Full Prescribing Information, including Boxed Warning regarding ABUSE, MISUSE, AND ADDICTION. DYANAVEL® and LiquiXR® are registered trademarks of Tris Pharma, Inc.

Once daily extended release provides early onset and full day coverage MONMOUTH JUNCTION, N.J., Oct. 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 and . 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: 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 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 DYANAVEL® and LiquiXR® are registered trademarks of Tris Pharma, Inc. ©2022 Tris Pharma, Inc. All rights reserved.