AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) 26.1/5.2 mg, 39.2/7.8 mg, 52.3/10.4 mg capsules

Efficacy demonstrated
across clinical assessments1,2

  • SKAMP-C1 Primary and key secondary
    end points     Rapid and sustained improvment in
    classroom behaviors throughout the day
  • PERMP
    math tests2     Secondary end point Rapid 30-minute
    onset and extended
    13-hour duration
  • WREMB-R
    caregiver rating2     Secondary end point Significant behavior
    improvement     overall in the morning and evening

Improves ADHD classroom behaviors throughout the day1,2

Primary end point: LS mean change from baseline
in SKAMP-C scores averaged over 13 hours1,2,a,b

The efficacy of AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) was evaluated in a multicenter, dose-optimized, randomized, double-blind, placebo-controlled, parallel-group, analog classroom study of 150 children (aged 6 - 12 years) with ADHD.1,2

  • AZSTARYS significantly lowered
    SKAMP-C scores assessing1,2
    • Attention
    • Deportment
    • Quality of Work
    • Compliance
VIEW CLOSE STUDY DESIGN

The efficacy of AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) was evaluated in a multicenter, dose-optimized, randomized, double-blind, placebo-controlled, parallel-group, analog classroom study of 150 children (aged 6-12 years) with ADHD.1,2

Screening and washout1

Open-label dose-optimization period (3 weeks)1

  • AZSTARYS 39.2 mg/7.8 mg was administered once daily in the morning
  • The dose could be titrated on a weekly basis to either 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg until an optimal dose or the maximum

Treatment phase1,2

  • After a 2-day washout period, patients were randomly assigned on a 1:1 basis, stratified by site, to either continue receiving the individually optimized dose of AZSTARYS or placebo for 7 days
  • The patients, investigators, and study sponsor were all blinded to treatment assignment

Efficacy assessments

  • Primary end point: the mean change from baseline (predose Visit 5) in SKAMP-C scores averaged across the test day (not including baseline score), with assessments conducted at 0.5, 1, 2, 4, 8, 10, 12, and 13 hours post dose1
  • Key secondary end point: the mean change from baseline (predose Visit 5) in SKAMP-C scores measured at each time point, with statistically significant differences used to determine onset and duration of efficacy2
  • Additional secondary end points2
    • Mean change from baseline (predose Visit 5) in PERMP scores at each time point across the classroom day (Visit 6)
    • Assessment of WREMB-R scores at baseline (Visit 2), Visit 5, and Visit 6
  • Exploratory end points (results not included in this presentation)
    • Changes in Conners 3-P scores week to week during the dose-optimization and treatment phases3
    • Changes in ADHD-RS-5 scores week to week during the dose-optimization phase2

Validated ADHD rating scales

SKAMP: a 13-item assessment of classroom behaviors in children with ADHD, including attention, deportment, quality of work, and compliance2

PERMP: a skill-adjusted 10-minute math test used to assess attention in children with ADHD. PERMP-A measures the number of math problems attempted, and PERMP-C measures the number of math problems answered correctly.2

WREMB-R: an 11-item parent-rated questionnaire developed to assess behaviors for severity during morning and evening hours.2

Conners 3-P: a 43-item parent/caregiver report that provides evaluation of inattention, hyperactivity/impulsivity, learning problems, executive functioning, defiance/aggression, and peer relations.3

ADHD-RS-5: an 18-item scale based on DSM-5 criteria of ADHD that rates symptom severity and frequency.2

ADHD-RS-5, Attention Deficit Hyperactivity Disorder–Rating Scale-Fifth Edition; Conners 3-P, Conners Third Edition-Parent; DSM-5, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; PERMP, Permanent Product Measure of Performance; PERMP-A, Permanent Product Measure of Performance-Attempted; PERMP-C, Permanent Product Measure of Performance-Correct; SKAMP, Swanson, Kotkin, Agler, M-Flynn, and Pelham; SKAMP-C, Swanson, Kotkin, Agler, M-Flynn, and Pelham-Combined; WREMB-R, Weekly Rating of Evening and Morning Behavior-Revised.

CLOSE STUDY DESIGN

aSKAMP is a 13-item assessment of classroom behaviors in children with ADHD, including attention, deportment, quality of work, and compliance.

bPredose Visit 5 as baseline. Baseline score was 17.9 for both groups.

cDifference (active drug minus placebo) in LS mean change from baseline.

Explore data on rapid onset, extended duration, and
assessment of challenges from morning to evening1

Select a study

Rapid onset and extended duration of
efficacy throughout the day1,2

AZSTARYS lowered mean
SKAMP-C scores at at every time point
measured throughout the day1,a

Key secondary end point: mean change from baseline in
SKAMP-C scores at each time point1

  • Rapid onset for
    the early
    morning routine1,2
  • Sustained control of
    symptoms during and
    after school1,2
  • Smooth and
    gradual offset through
    the evening1,2

Onset of effect was defined as the first time point showing a statistically significant difference vs placebo. Duration of effect was defined as the length of time between the first and last time points showing statistical significance vs placebo, or the last measured time point.2,a,b

aSKAMP is a 13-item assessment of classroom behaviors in children with ADHD, including attention, deportment, quality of work, and compliance.2

Image of two children sitting at the dinner table Image of two children sitting at the dinner table

The first and only SDX prodrug
designed for continuous
conversion to d-MPH

Flexible and convenient
dosing and administration

d-MPH, dexmethylphenidate; LS, least squares; PERMP, Permanent Product Measure of Performance; PERMP-A, Permanent Product Measure of Performance-Attempted; PERMP-C, Permanent Product Measure of Performance-Correct; SKAMP, Swanson, Kotkin, Agler, M-Flynn, and Pelham; SKAMP-C, Swanson, Kotkin, Agler, M-Flynn, and Pelham-Combined; WREMB-R, Weekly Rating of Evening and Morning Behavior-Revised.

References: 1. AZSTARYS. Prescribing information. Corium Inc; 2021. 2. Kollins SH, Braeckman R, Guenther S, et al. A randomized, controlled laboratory classroom study of serdexmethylphenidate and d-methylphenidate capsules in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2021;31(9):597-609. doi:10.1089/cap.2021.0077 3. Data on file. Corium, Inc. 4. Wehmeier PM, Dittmann RW, Schacht A, Helsberg K, Lehmkuhl G. Morning and evening behavior in children and adolescents treated with atomoxetine once daily for attention-deficit/hyperactivity disorder (ADHD): findings from two 24-week, openlabel studies. Child Adolesc Psychiatry Ment Health. 2009;3(1):5. doi:10.1186/1753-2000-3-5

INDICATION

AZSTARYS is a central nervous system
(CNS) stimulant indicated for the
treatment of Attention Deficit
Hyperactivity Disorder
(ADHD) in
patients 6 years and older.

Important Safety
Information

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants, including
    AZSTARYS, other methylphenidate-
    containing products, and
    amphetamines, 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

Contraindications

  • Known hypersensitivity to
    serdexmethylphenidate,
    methylphenidate, or other product
    components. Bronchospasm, rash,
    and
    pruritus have occurred with
    AZSTARYS. Hypersensitivity reactions
    such as angioedema and anaphylactic
    reactions have occurred
    with other
    methylphenidate products.
  • Concomitant treatment with a
    monoamine oxidase inhibitor (MAOI)
    or use of an MAOI within the
    preceding 14 days, because of
    the risk
    of hypertensive crisis.

Warnings and Precautions

  • Sudden death has been reported in
    association with CNS stimulant
    treatment at recommended doses in
    pediatric patients with
    structural
    cardiac abnormalities or other
    serious heart problems. In adults,
    sudden death, stroke, and myocardial
    infarction have
    been reported at
    recommended doses. Avoid use in
    patients with known structural
    cardiac abnormalities, cardiomyopathy,
    serious heart arrhythmias, coronary artery disease, or other serious heart problems.
  • CNS stimulants cause an increase in
    blood pressure and heart rate. Monitor
    all patients for hypertension and
    tachycardia.
  • Exacerbation of Pre-existing
    Psychosis    : May exacerbate symptoms
    of behavior disturbance and thought
    disorder in patients with
    a pre-existing
    psychotic disorder. Induction of a
    Manic Episode in Patients with Bipolar
    Disorder    : May induce a mixed/manic
    episode in patients with bipolar
    disorder. Prior to initiating treatment,
    screen for risk factors for developing a
    manic episode (e.g.,
    comorbid or
    history of depressive symptoms, or a
    family history of suicide, bipolar
    disorder, or depression). New
    Psychotic or
    Manic Symptoms    : At
    recommended doses, may cause
    psychotic or manic symptoms (e.g.,
    hallucinations, delusional thinking, or
    mania) in patients without a history of
    psychotic illness or mania. Discontinue
    if symptoms occur.
  • 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.
  • CNS stimulants, including AZSTARYS,
    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.
    Carefully
    observe patients during
    treatment for digital changes. Further
    evaluation may be required, including
    referral.
  • CNS stimulants have been associated
    with weight loss and slowing of
    growth rate in pediatric patients.
    Monitor height and weight
    at
    appropriate intervals in pediatric
    patients. Treatment may need to be
    interrupted in children not growing or
    gaining weight as
    expected.

Adverse Reactions

  • 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, and blood
    pressure increased.

Drug Interactions

  • Adjust dosage of antihypertensive
    drug as needed. Monitor blood
    pressure.
  • Avoid use of AZSTARYS on the day of
    surgery if halogenated anesthetics
    will be used.

Please click here for Full
Prescribing Information,
including Boxed WARNING.

INDICATION

AZSTARYS is a central nervous system
(CNS) stimulant indicated for the
treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in
patients 6 years and older.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants, including AZSTARYS, other methylphenidate-containing products, and amphetamines, 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