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

Clinical trial experience with other MPH products in patients with ADHD1

Commonly reported (≥5% of the MPH group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of MPH products included decreased appetite, decreased weight, nausea, abdominal pain, dyspepsia, vomiting, insomnia, anxiety, affect lability, irritability, dizziness, increased blood pressure, and tachycardia.

Incidence of TEAEs occurring in ≥2% of patients (aged 6-12 years) in any treatment group in a placebo-controlled study of AZSTARYS2

Because of the study design, the reported adverse reaction rates cannot be used to predict the rates that may be expected in clinical practice.

Study Design1,2

A short-term, randomized, double-blind, placebo-controlled, parallel-group study conducted from December 2017 to May 2018 in pediatric patients aged 6 to 12 years with ADHD.

Study phases

  • A 3-week, open-label, dose-optimization phase in which all patients received AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) (N=155). Five patients discontinued treatment during this phase
  • Followed by a 1-week, double-blind, controlled phase in which patients were randomized to continue AZSTARYS (n=74) or switch to placebo (n=76)

Effect on sleep behavior in patients treated with AZSTARYS2

Secondary end point: mean CSHQb sleep disturbance score by visit2,c

Due to the open-label study design, conclusions and significance cannot be extrapolated.1

Sleep behavior was assessed in an open-label, long-term safety trial
by using the modified CSHQ in patients aged 6 to 12 years.2,a,b

  • Before treatment, most patients reported sleep disturbances (mean CSHQ score: 53.5)
  • Mean sleep quality scores improved slightly during treatment (mean CSHQ score at Month 12: 49.1)

a Multicenter, multiple-dose, dose-optimized, open-label safety study administering AZSTARYS to children with ADHD for approximately 360 days (N=282).1,2

b The modified CSHQ (a 33-item parent questionnaire) is used to assess sleep behavior in children. Each item is rated on a 3-point scale of usually, sometimes, and rarely. Lower scores indicate improvement. The clinical cutoff score (boundary between the group with sleep disorders and the general population) is ≥41.2

c The data were evaluated using the efficacy population (n=225).2

Effect on weight and height in patients treated with AZSTARYS1

Weight and height changes in patients aged 6 to 12 years over 12 monthsa

Mean increase Mean z-scoreb
Weight 3.4 kg -0.20
Height 4.9 cm -0.21

Because of the open-label, uncontrolled design of this study, the reported adverse reaction rates cannot be assessed in terms of a causal relationship to
AZSTARYS treatment.

Mean change in z-scores from baseline to Month 12 for both weight and height indicated a lower-than-expected increase compared with children of the same age and sex, on average.
A z-score change <0.5 SD is considered not clinically significant.

aA long-term, open-label safety study was conducted in pediatric patients aged 6 to 12 years with ADHD. This study was composed of a 3-week dose-optimization phase for patients not recently treated with AZSTARYS (from the primary short-term study), followed by a 12-month treatment phase for all patients during which 238 received open-label AZSTARYS and had evaluable safety data. A total of 154 patients were treated for 12 months.

bZ-scores show the SD above or below the mean weight or height normalized for the natural growth of children and adolescents by comparison to age- and sex-matched population standards.

Two boys doing homework in a library Two boys doing homework in a library

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

Sustained
symptom coverage

throughout the day

ADHD, Attention Deficit Hyperactivity Disorder; CSHQ, Children's Sleep Habit Questionnaire; d-MPH, dexmethylphenidate; MPH, methylphenidate; SDX, serdexmethylphenidate; TEAE, treatment-emergent adverse event.

References: 1. AZSTARYS. Prescribing information. Corium Inc; 2021. 2. Data on file. Corium, Inc.

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