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For patients 6 years and older with ADHD

DYANAVEL XR Tablet Was Studied in Adults From 30 Minutes to 14 Hours1

The effect of DYANAVEL XR tablet on symptoms of ADHD in adults was measured by PERMP-T* scores1,2

  • The primary efficacy endpoint—the mean PERMP-T score across all postdose time points at Visit 5 (last visit)—was met (DYANAVEL XR (amphetamine) tablet: 302.8 [87.57]; placebo: 279.6 [79.77]; P=0.0043)

Improvement in Attention With DYANAVEL XR Tablet vs Placebo1

The response over time of DYANAVEL XR tablet was also measured by comparing PERMP-T scores between groups at all time points postdose.

Graph: Improvement In Attention With DYANAVEL XR Tablet vs Placebo From 30 Minutes to 14 Hours

Post hoc analysis by sequential time points: PERMP-T scores at 30 minutes and 1, 2, 4, 8, and 13 hours postdose were statistically significantly higher with DYANAVEL XR tablet compared with placebo (P0.05)2

Study Design: This study employed a 5-week forced dose–titration phase. Eligible subjects aged 18 to 60 years were randomized to either oral, double-blind DYANAVEL XR tablet 5-mg starting dose or matching placebo once daily in the morning, beginning the day after the baseline visit. Subjects were titrated up (5-mg increments) each week. Safety and efficacy assessments were done weekly. After Visit 3, subjects received 20 mg for 14 (±3) days before Visit 5. Subjects who could not tolerate the study drug were discontinued. A PERMP placement test was done at screening or baseline. At Visit 5, efficacy assessments included the administration of serial PERMPs predose and 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours postdose.1,2

Safety data for
DYANAVEL XR tablet caret

*

The PERMP is a validated, time-sensitive, skill-adjusted test consisting of math problems to be completed at multiple time points (administration of serial PERMPs). It is a robust, objective measure of the ability to initiate a task, self-monitor/stay on task, and complete written seatwork. The PERMP does not test for mathematical ability or the ability to learn math because the difficulty of problems is adjusted to the existing math skill level of each participant.2

Standard error.2

 

PERMP-T, Permanent Product Measure of Performance Total.

 

References: 1. Cutler AJ, Pardo A, King TR, Rafla E, Duhoux S, Kando JC. Poster presented at: The American Professional Society of ADHD and Related Disorders; January 15-17, 2021; virtual conference. 2. Data on file. Tris Pharma, Inc.

IMPORTANT SAFETY INFORMATION

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WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Dyanavel XR, Quillivant XR, QuilliChew ER, and other amphetamine-containing or methylphenidate-containing products, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Dyanavel XR, Quillivant XR, QuilliChew ER, and other amphetamine-containing or methylphenidate-containing products, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

  • Dyanavel XR (amphetamine), Quillivant XR (methylphenidate HCl), and QuilliChew ER (methylphenidate HCl) are contraindicated:
    • in patients known to be hypersensitive to amphetamine, methylphenidate, or other components of Dyanavel XR, Quillivant XR, and QuilliChew ER. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported.
    • in patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs, because of risk of hypertensive crisis.
  • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, and other serious cardiac problems. Sudden death, stroke, and myocardial infarction have been reported in adults treated with CNS stimulants at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious cardiac problems when taking CNS stimulants at recommended doses for ADHD. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with Dyanavel XR, Quillivant XR, and QuilliChew ER.
  • CNS stimulants cause increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for tachycardia and hypertension.
  • CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. They may induce a mixed/manic episode in patients with bipolar disorder. Assess for presence of bipolar disorder prior to initiating treatment. At recommended doses, stimulants may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania, in patients without prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Dyanavel XR, Quillivant XR, or QuilliChew ER.
  • 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, Quillivant XR, and QuilliChew ER. Treatment may need to be interrupted in children not growing or gaining weight as expected.
  • CNS stimulants 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.
  • Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.
  • Serotonin syndrome risk is increased when Dyanavel XR is 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.
  • QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU).
  • 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%).
  • Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are: appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, blood pressure increased.
  • There is limited experience with Quillivant XR and QuilliChew ER in controlled trials.
    • Quillivant XR: The most common (≥2% in the Quillivant XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6 to 12 years) in Quillivant XR compared to placebo were affect lability (9% Quillivant XR, 2% placebo), excoriation (4%, 0%), initial insomnia (2%, 0%), tic (2%, 0%), decreased appetite (2%, 0%), vomiting (2%, 0%), motion sickness (2%, 0%), eye pain (2%, 0%), and rash (2%, 0%).
    • QuilliChew ER: The most common (≥2% in the QuilliChew ER group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 90 pediatric subjects (ages 6 to 12 years) in QuilliChew ER compared to placebo were decreased appetite (2.4% QuilliChew ER, 0% placebo), aggression (2.4%, 0%), emotional poverty (2.4%, 0%), nausea (2.4%, 0%), headache (2.4%, 0%), and weight decreased (2.4%, 0%).
  • Dyanavel XR, Quillivant XR, and QuilliChew ER use during pregnancy may cause fetal harm.
  • Breastfeeding is not recommended during treatment with Dyanavel XR, Quillivant XR, or QuilliChew ER.

INDICATION

Dyanavel XR, Quillivant XR, and QuilliChew ER are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

See Full Prescribing Information for Dyanavel XR, Quillivant XR, and QuilliChew ER, including Boxed Warning regarding Abuse and Dependence.

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