Tris Pharma Announces FDA Approval of DYANAVEL® XR (amphetamine) Once-Daily Extended-Release Oral Tablets, CII, for ADHD

MONMOUTH JUNCTION, N.J., Nov. 5, 2021 /PRNewswire/ -- Tris Pharma (Tris) announced today that the U.S. Food and Drug Administration has approved Dyanavel XR (amphetamine), extended release once-daily tablets, CII, for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

In a clinical study in healthy adults, DYANAVEL XR extended-release tablets were deemed to be bioequivalent to DYANAVEL XR extended-release oral suspension, which in a Phase 3 clinical study of 6 to12 year-old children with ADHD, demonstrated ADHD symptom improvement within 1 hour, that lasted through 13 hours after once-daily dosing. Further, in a separate exploratory study, DYANAVEL XR oral suspension appeared to improve ADHD symptoms as soon as 30 minutes after dosing (Pardo, et al. CNS Spectrums 2020 Dec:25(6):774-781).

In a separate 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 post-dose time points measured (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 (at least 5%) adverse reactions were insomnia, dry mouth, headache, irritability, nausea, dizziness, initial insomnia and tachycardia. Tris plans to submit these findings for publication in a peer-reviewed scientific journal and to FDA at a future date.

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.

“The Dyanavel XR Tablet represents an important treatment option for patients with ADHD,” said Andrew J. Cutler, CMO, Neuroscience Education Institute and Clinical Associate Professor of Psychiatry, SUNY Upstate Medical University. “Knowing that ADHD in adults presents differently than in children, and as different adults have different treatment goals, DYANAVEL XR once-daily tablet was designed and developed with the intent to provide adults with ADHD a treatment option that kicks in quickly and lasts throughout their workday and beyond.”

The approval of DYANAVEL XR tablets expands Tris’ ADHD portfolio and highlights Tris’ commitment to address the unmet needs of the ADHD community. Nearly 10 million adults in the U.S. have ADHD. Over 90% of cases are untreated and at least 75% of adults who have ADHD don’t know it. Offering DYANAVEL XR in a tablet formulation gives healthcare professional a new option when treating adults with ADHD.

“The approval of DYANAVEL XR tablets, which utilize Tris’ LiquiXR® technology platform, fills an important gap in Tris’ portfolio of ADHD products to fit the needs of a variety of patient types. Dyanavel XR oral suspension and now DYANAVEL XR tablets provide a unique pharmacokinetic profile and a broad range of dosing options for patients needing an amphetamine for their ADHD”, said Dr. James Hackworth, President of the Tris Branded Products Division.

DYANAVEL XR tablets are expected to be stocked in pharmacies in the first quarter of 2022.

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 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.

About Tris Pharma
Tris Pharma is a New Jersey-based pharmaceutical company focused on the development and commercialization of innovative medicines that address unmet patient needs. Tris has used its innovative LiquiXR technology platform to develop its portfolio of differentiated solid and liquid medications as well as a robust pipeline which spans multiple therapeutic categories, and its technology has formed the basis for numerous mutually value-adding development partnerships. Within the United States, Tris promotes its portfolio of ADHD products (described at www.TrisADHD.com) using its pediatric and psychiatry-focused sales force. For more information, please visit www.trispharma.com.

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SOURCE Tris Pharma, Inc.