Study Results | DYANAVEL XR (amphetamine) Tablet | Tris Pharma
Important Safety Information Medication Guide and Prescribing Information
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Proven 13-hour efficacy1

Discover symptom control through the day with DYANAVEL XR (amphetamine)1,2

Improvement in Attention and Behavior With
DYANAVEL® XR (amphetamine) Oral Suspension vs Placebo1


Graph: Statistically Significant Improvement In Attention and Behavior With DYANAVEL XR Oral Suspension vs Placebo

Primary endpoint: Significant improvement in SKAMP-combined score at 4 hours postdose vs placebo (P<0.0001)*1

Study Design: 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.

Safety Information from Clinical Study: Treatment-Emergent Adverse Events (TEAEs) (≥5%) Reported During the 5-Week Open-label, Dose-optimization Period: Decreased appetite, Insomnia, Affect lability, Upper abdominal pain, Mood swings, Headache.

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 Period: Epistaxis. Allergic rhinitis, Upper abdominal pain.

* 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


LS, least squares.

Improvement in Attention With DYANAVEL® XR Tablet vs Placebo2

Improvement in Attention With DYANAVEL XR Tablet vs Placebo Efficacy Chart

Study Design: This study employed a 5-week forced dose–titration phase. Eligible subjects aged 18 to 60 years who met DSM-5 criteria for ADHD were randomized to double-blind DYANAVEL XR tablet or matching placebo, taken orally once daily beginning the day after the baseline visit. Subjects were titrated from a 5mg starting dose up by 5-mg increments each week until a final dose of 20mg for 14 ± 3 days prior to visit 5. Subjects who could not tolerate the study drug were discontinued. At Visit 5, efficacy assessments included the administration of serial PERMPs predose and at 0.5, 1, 2, 8, 10, 12, 13, and 14 hours postdose. Safety and tolerability were assessed at each study visit, including direct questioning about sleep, appetite, mood, and psychotic adverse events.2

Safety Information from Clinical Study: In the forced-dose, double-blind phase 3 study conducted in adults, no serious adverse events reported. In the study the most commonly reported treatment-emergent adverse events (TEAEs) (>5%) in the DYANAVEL® XR Tablet group and greater than placebo were: Decreased appetite, Insomnia, Dry mouth, Irritability, Headache, Dizziness, Initial insomnia, Nausea, Tachycardia, Anxiety.

DYANAVEL XR was shown to improve ADHD symptoms compared to placebo when measured with a standardized performance test, the PERMP**, a that measures the ability to initiate a task, self-monitor/stay on task, and complete written seatwork.

The primary efficacy endpoint—the mean PERMP-T score across all postdose time points at Visit 5 (last visit)—was statistically significantly higher in the DYANAVEL XR tablet group than in the placebo group (P = 0.0043)

See how DYANAVEL XR tablet provides continuous medication release4

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DYANAVEL XR tablet has 8 different dosing options.

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* 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.5

PERMP-T, Permanent Product Measure of Performance Total.

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‡References: 1. 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. 2. 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(5):22m14438 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. CNS Spectr. 2020;25(6):774-781. 5. Wigal SB. Laboratory school protocol minireview: Use of direct observational and objective measures to assess ADHD treatment response across the lifespan. Front. Psychol. 2019;10:1796.

Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine) is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep DYANAVEL XR in a safe place to prevent abuse and misuse. 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.

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

Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine) is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep DYANAVEL XR in a safe place to prevent abuse and misuse. 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.

– Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with DYANAVEL XR and will monitor you or your child during treatment.

– 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 including the antibiotic linezolid and the intravenous medicine methylene blue.

DYANAVEL XR can cause serious side effects including:

  • Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease. Before starting DYANAVEL XR, tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
    Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DYANAVEL XR.
  • Increase in blood pressure and heart rate.
    Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with DYANAVEL XR.
  • Mental (psychiatric) problems, including new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms.
    Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
    Call the doctor right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with DYANAVEL XR.
  • New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with DYANAVEL XR.
  • Serotonin Syndrome. This problem may happen when DYANAVEL XR is taken with certain other medicines and may be life-threatening. Stop taking DYANAVEL XR and call your healthcare provider or go to the nearest hospital emergency room if you get symptoms such as 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.
  • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with DYANAVEL XR. Your healthcare provider may stop your child’s DYANAVEL XR treatment if they are not growing or gaining weight as expected.
  • It is not known if DYANAVEL XR will harm the unborn baby. There is a pregnancy registry for females who are exposed to DYANAVEL XR during pregnancy. The purpose of the registry is to collect information about the health of females exposed to DYANAVEL XR and their baby. If you or your child becomes pregnant during treatment with DYANAVEL XR, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
  • DYANAVEL XR passes into breast milk. You or your child should not breastfeed during treatment with DYANAVEL XR. Tell your doctor if you are breastfeeding or plan to breastfeed.
  • The most common side effects of amphetamine products include:

    – dry mouth

    – decreased appetite

    – weight loss

    – stomach pain

    – nausea

    – trouble sleeping

    – restlessness

    – extreme mood changes

    – dizziness

    – increased heart rate

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.

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

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.

Please see Full Prescribing Information, including Boxed Warning about Abuse, Misuse and Addiction and Medication Guide.

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