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

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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
Mean sleep quality scores slightly improved during AZSTARYS® treatment.

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 LLC; 2021. 2. Data on file. Corium LLC.

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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