Skip to Main Content

Clinical Resource Center

DYANAVEL® XR (amphetamine) studies and data

IR Supplementation IR Supplementation Delivery Technology Delivery Technology Efficacy Efficacy Economic Evaluation Economic Evaluation

Real World Evidence in ADHD

In a retrospective study evaluating patient variables associated with IR supplementation among ADHD patients taking ER stimulants:1

DYANAVEL XR was associated with reduced IR supplementation at 90 days. 98% of 143 patients taking DYANAVEL XR did not receive IR supplementation.1

In an exploratory PATH analysis, DYANAVEL XR independently reduced end-of-dose crash and reduced IR supplementation. However, end-of-dose crash was not significantly associated with IR supplementation.1

IR Supplementation Read Full Study Study Results Video

Extended-release amphetamine (Dyanavel XR) is associated with reduced immediate-release supplementation in adults with ADHD, regardless of baseline patient variables: a retrospective cohort analysis of medical treatment records1

Young JL, Powell RN, et al. BMC Psychiatry (2025) 25:12 https://doi.org/10.1186/s12888-024-06446-z

Proven Efficacy in Patients with ADHD2

Improvement in Attention and Behavior With DYANAVEL® XR Oral Suspension vs Placebo2

Primary endpoint: Significant improvement from predose SKAMP-combined score at 4 hours postdose vs placebo (P<0.0001)

LS, least squares

Secondary endpoints: Significant improvement from predose SKAMP-combined scores at each timepoint measured postdose (1, 2, 6, 8, 10, 12 & 13 hrs) vs placebo (P<0.0001 for each)

LS, least squares

Study Details: This dose-optimized, randomized, double-blind, placebo-controlled laboratory classroom study included 99 children aged 6 to 12 years who met DSM-IV-TR criteria for ADHD. In the 5 week open-label dose-optimization period, patients received a starting dose of 2.5 or 5mg of DYANAVEL XR taken once daily in the morning. The dose was titrated by 2.5mg to 10mg increments every 4 to 7 days until an optimal dose or the maximum daily dose of 20mg/day was reached. Patients who achieved an optimal dose during the dose optimization period entered the double blind portion of the study where they were randomized to either DYANAVEL XR at their optimal dose or placebo once daily for one week. E cacy was assessed on the final day of the double-blind phase, by teachers and raters using the SKAMP rating scale. The primary endpoint was the change from predose in the model-adjusted average of SKAMP-combined score at 4 hours postdose. Secondary endpoints looked at change from predose SKAMP-combined scores at 1, 2, 6, 8, 10, 12 and 13 hours postdose.

LS, least squares

The SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) rating scale, often used in clinical trials, is a validated rating instrument, used by trained raters to specifically measure the observed classroom manifestations of ADHD. The items of the SKAMP are specific for place (the classroom) and time (a typical class period). The scale's items describe typical behaviors in a classroom setting, and additional items that describe behaviors associated with ADHD in the classroom. The SKAMP method of assessment has been demonstrated to be a sensitive measure of attention and behavior within a lab classroom setting.

LS, least squares

In an optimized-dose, double-blind phase 3 study conducted in pediatric patients, most adverse events were classified as mild in severity2

Treatment-Emergent Adverse Events (TEAEs) (≥5%) Reported During the 5-Week Open-label, Dose-optimization Period2

Most Common Treatment-Emergent Adverse Events (TEAEs) (≥2%) in the DYANAVEL® XR Oral Suspension Group and Greater than Placebo During the 1-Week, Double-blind Period22

Understanding Differences in Delivery Technologies

for ADHD Stimulant Medications

Explore a February 2025 review article that examines the benefits and limitations of various ADHD stimulant delivery technologies and discusses how understanding these differences may help healthcare providers individualize treatment decisions.

IR Supplementation Technology Paper

Understanding the delivery technology used in ADHD stimulant medications can help to individualize treatment (Cutler AJ, Hanai J. CNS Spectrums, 30(1), e30, 1-13)

Hourglass Video DYANAVEL XR Pharmacokinetics

Watch a brief video overview of how DYANAVEL XR uses advanced delivery technology to provide continuous amphetamine release throughout the day.

Access ADHD resources and support

A Physician's Personal Experience with ADHD

Dr. Jonathan Mason was first diagnosed with ADHD when taking his medical boards. In this video he discusses his diagnosis and treatment journey with his physician and mentor, Dr. George Bright.

Joel Young, MD, discusses Extended-release amphetamine (Dyanavel XR) is associated with reduced immediate-release supplementation in adults with ADHD, regardless of baseline patient variables: a retrospective cohort analysis of medical treatment records

What are the predictors of IR supplementation in patients on extended-release stimulants? Dr. Joel Young conducted a study to better understand which factors influence whether patients add a short-acting medication to their daily extended-release treatment.

Medical Resources

IR Supplementation

Access in-depth clinical information and a wide variety of resources on ADHD and related conditions at TrisMedical.com.

Request Medical Information

Guaranteed availability and patient savings

You prescribe. We deliver.

ePrescribe to Perigon Pharmacy 360 for guaranteed availability, patient support, lowest available price, and free, fast delivery.

  • $25 for commercially-insured patients with DYANAVEL XR coverage*
  • $100 for patients who choose to pay cash*

See Details

Questions? Call 1.844.698.2533 for live support
Available Monday-Friday 9 AM-6 PM ET
California residents please call 1.850.874.2025

Help your patients save on DYANAVEL XR.

Eligible patients pay as little as $25 on each prescription.**

Access Savings Cards

Connect with a Tris Pharma representative

Enter your contact information to learn more about DYANAVEL XR.

*Perigon Pharmacy 360 works directly with Tris Pharma to ensure DYANAVEL XR tablets are always available.

**Savings offer is subject to eligibility. Terms and Conditions apply.

REFERENCES 1. Young JL, Powell RN, Powell A, Welling LLM, Granata L, Saal J, Nash M. Extended-release amphetamine (Dyanavel XR) is associated with reduced immediate-release supplementation in adults with ADHD, regardless of baseline patient variables: a retrospective cohort analysis of medical treatment records. BMC Psychiatry. 2025 Jan 3;25(1):12. 2. Childress AC, Wigal SB, Brams MN, et al. Efficacy and safety of amphetamine extended-release oral suspension in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psycholpharmacol. 2018;28(5):306-313. 3. Wigal SB, Gupta S, Guinta D, Swanson JM. Reliability and validity of the SKAMP rating scale in a laboratory school setting. Psychopharmacol Bull. 1998;34(1):47-53. 4. 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. 5. Cutler AJ, Hanaie J. Understanding the delivery technology used in ADHD stimulant medications can help to individualize treatment. CNS Spectrums. 2025;30(1):e30.

IMPORTANT SAFETY INFORMATION & APPROVED USE

isi open close button

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 DYANAVELXR, 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.

INDICATION

DYANAVEL® XR (amphetamine) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Limitations of use

The use of DYANAVEL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

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 DYANAVELXR, 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 a manic 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. DYANAVEL XR is not approved for use and is not recommended in pediatric patients below 6 years of age. Closely monitor height and weight in DYANAVEL XR treated pediatric patients treated with CNS stimulants. Treatment may need to be interrupted in children not growing or gaining height or weight 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 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 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 https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
  • 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 (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information including BOXED WARNING regarding ABUSE, MISUSE, and ADDICTION.

You are now leaving this website

You are about to leave DYANAVELXRhcp.com and enter a website operated by a third party. Would like to continue?

Yes
You are now leaving this website

You are about to leave DYANAVELXRhcp.com and enter a website operated by a third party. Would like to continue?

Yes