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

With an IR d-MPH and
SDX prodrug, AZSTARYS
provides efficacy
throughout the day1

Improvement in ADHD symptoms was demonstrated using SKAMP, a 13-item validated
assessment of classroom behaviors in children with ADHD,1 including3,4,a

  • Attention
  • Deportment
  • Quality of
    written work
  • Compliance

AZSTARYS significantly lowered
SKAMP-C scores averaged over
the 13-hour classroom day1

There was a significant -5.41 placebo-subtracted difference in mean SKAMP-C scores with AZSTARYS™ vs placebo
img

Primary end point: mean change from baseline of SKAMP-C scores averaged over 13 hours.
Assessments were conducted at baseline and 0.5, 1, 2, 4, 8, 10, 12, and 13 hours post dose.
The LS mean change from baseline was -4.87 with AZSTARYS and 0.54 with placebo.1

aDecrease in SKAMP-C scores indicates symptom improvement.1

bBaseline score was assessed at predose on the practice classroom day/randomization visit after
2 days of active drug washout.1

cDifference (active drug minus placebo) in LS mean change from baseline.1

Rapid onset and extended duration of
efficacy with a once-daily dose1

Graph shows AZSTARYS™ lowered mean SKAMP-C scores from baseline, 30 minutes through 13 hours
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VIEW STUDY DESIGN1

The efficacy of AZSTARYS was evaluated in a randomized,
double-blind, placebo-controlled, parallel-group, analog
classroom study of 150 pediatric patients (aged 6-12 years) who
were diagnosed with ADHD.

Screening and washout

Open-label dose-optimization period (3 weeks)

  • AZSTARYS 39.2 mg/7.8 mg administered once daily in the morning
  • The dose could be titrated weekly 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 dose (52.3 mg/10.4 mg) was reached

Treatment period (1 week)

  • Patients were randomly assigned to either continue receiving the individually optimized dose of AZSTARYS or placebo

Raters evaluated the attention and behavior of patients in a laboratory classroom setting over 13 hours using the SKAMP-C rating scale. SKAMP is a validated, 13-item, teacher-rated scale that assesses ADHD symptoms in a classroom setting

Primary end point: mean change from baseline (predose at
randomization visit) of the 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 dose.

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; GI, gastrointestinal; IR, immediate-release; SDX, serdexmethylphenidate.

References: 1. AZSTARYS. Prescribing information.
Corium Inc; 2021. 2. Mickle T, Guenther S, Chi G,
inventors; KemPharm, Inc, assignee. Methylphenidate-
prodrugs, processes of
making and using the same.
U.S. patent 10,584,113. March 10, 2020. 3. Childress
AC, Komolova M, Sallee FR. An update on the
pharmacokinetic considerations in the treatment of
ADHD with long-acting methylphenidate and
amphetamine formulations. Expert Opin Drug Metab
Toxicol. 2019;15(11):937-974.
doi:10.1080/17425255.2019.1675636 4. Patrick
KS,
Radke JL, Raymond JR, et al. Drug regimen
individualization for attention-deficit/hyperactivity
disorder: guidance for methylphenidate and
dexmethylphenidate formulations.
Pharmacotherapy.
2019;39(6):677-688. doi:10.1002/phar.2190 5. Gudin JA, Nalamachu SR. An overview of prodrug technology and its application for developing abuse-deterrent opioids. Postgrad Med. 2016;128(1):97-105. doi:10.1080/00325481.2016.1126186

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, and 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