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

AZSTARYS® is available nationwide

Efficacy demonstrated
across clinical assessments1,2

  • SKAMP-C1 Primary and key secondary
    end points     Rapid and sustained improvement 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

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

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
AZSTARYS® study design timeline.

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 every time point
measured throughout the day1,a

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

Graph shows AZSTARYS® lowered mean SKAMP-C scores from baseline, 30 minutes through 13 hours.
  • 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 LLC; 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 LLC. 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, open-label 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, MISUSE, AND ADDICTION

AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

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 in patients treated 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 patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid AZSTARYS use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
  • CNS stimulants cause an increase in blood pressure and heart rate. Monitor all AZSTARYS-treated patients for hypertension and tachycardia.
  • Exacerbation of Pre-existing Psychosis: CNS stimulants 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: CNS stimulants may induce a mixed mood/manic episode in patients with bipolar disorder. Prior to initiating AZSTARYS 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: CNS stimulants at the recommended dosage may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a history of psychotic illness or mania. Consider discontinuing AZSTARYS if symptoms occur.
  • Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate use, in both adult and pediatric male patients. AZSTARYS-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
  • CNS stimulants, including AZSTARYS, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Carefully observe patients during AZSTARYS treatment for digital changes. Further clinical evaluation may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor height and weight at appropriate intervals in AZSTARYS-treated pediatric patients. Treatment may need to be interrupted in pediatric patients not growing or gaining weight as expected.
  • Angle closure glaucoma associated with methylphenidate treatment has been reported. AZSTARYS-treated patients considered at risk for acute angle closure glaucoma should be evaluated by an ophthalmologist.
  • Elevation of intraocular pressure (IOP) associated with methylphenidate treatment has been reported. Use of AZSTARYS with patients who have open-angle glaucoma or abnormally increased IOP should only be considered if the benefit of treatment outweighs the risk. Closely monitor AZSTARYS-treated patients with a history of abnormally increased IOP or open angle glaucoma.
  • CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating AZSTARYS, assess family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor AZSTARYS-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

Adverse Reactions

  • Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are decreased appetite, decreased weight, nausea, abdominal pain, dyspepsia, vomiting, insomnia, anxiety, affect lability, irritability, dizziness, increased blood pressure, and tachycardia.

Drug Interactions

  • Adjust dosage of antihypertensive drug as needed. Monitor blood pressure.

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, MISUSE, AND ADDICTION

AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

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