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Clinical Update:

Real World Evidence in ADHD

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

Read Full Study Watch Video on the Study

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

Real World Evidence in ADHD

Clinical Update:

Understanding the delivery technology used in ADHD stimulant medications can help to individualize treatment

February 2025 review article discusses benefits and restrictions of various stimulant delivery technologies to help guide healthcare providers in ADHD treatment decisions.

Read Full Study

Cutler AJ, and Hanaie J (2025). Understanding the delivery technology used in ADHD stimulant medications can help to individualize treatment. CNS Spectrums, 30(1), e30, 1–13. https://doi.org/10.1017/S1092852925000070

Understanding the delivery technology used in ADHD stimulant medications can help to individualize treatment

Proven efficacy at each timepoint for 13 hours2

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

Primary endpoint: Significant improvement from predose SKAMP-combined score at 4 hours postdose vs placebo (P<0.0001)*2

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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)*2

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.

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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.3

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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

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See how our advanced technology ensures amphetamine is released continuously through the day.4,5

Access ADHD resources and support

Resources for healthcare professionals

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.

Dr. Joel Young Discusses DYANAVEL XR and Reduced IR Supplementation

Listen to Dr. Joel Young discuss the recent retrospective study evaluating potential predictive variables for IR supplementation in patients with ADHD already taking ER stimulants.

Clinical Resources

Tris Medical: Click here to access in-depth clinical information and a wide variety of resources on ADHD and related conditions at TrisMedical.com.


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  • $25 for commercially-insured patients with DYANAVEL XR coverage*
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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

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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.

IMPORTANT SAFETY INFORMATION & APPROVED USE

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 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 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.

INDICATION

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

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

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